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Unlverstteit Vrystaat
A Comparative Analysis of Pressure
Sore Treatment Modalities in
Community Settings
N. Small
un'versiteit van die
Or LnOJce-VOryNsTtEaIaNt
, 8 JU L 2002
u VS SASOL BIBLIOTEEK
A Comparative Analysis of Pressure
Sore Treatment Modalities in
Community Settings
by
Nico Small
Submitted in fuifiIIment of the requirements for the degree
Magister Socientatis Scientiae in Nursing
in the Faculty of Health Sciences, School of Nursing,
University of the Orange Free State
November 2000
Study Leader: Prof. M. Mulder
Co-study Leader: Mrs. M.J. Mackenzie
I hereby certify that this dissertation, which is submitted by me for the degree
Magister Socientatis Scientiae in Nursing at the University of the Orange Free
State, has not been submitted previously for any degree to any other
university.
I certify that this is my own work.
N. Small
ii
I wish to express my sincere gratitude to the following people and
organisations for their contributions towards the completion of this study.
o The participants of this study, their families and caregivers whose
contributions made this study possible.
o Smith and Nephew, for their support in providing wound care products
and seed funding.
o My study leaders, Prof. M. Mulder and Mrs. M.J. Mackenzie for their
guidance.
o Dr. L. Cullingworth, as study monitor for Smith and Nephew.
o The Department of Biostatistics within the Faculty of Health Sciences
at the University of the Orange Free State.
o My parents for their encouragement and support.
iii
eo [\IllrrENlS
ACKNOWLEDGEMENTS 111
CONTENTS IV
INDEX OF FIGURES, GRAPHS AND TABLES XV
CHAPTER ONE 1
1.1 INTRODUCTION 2
1.2 PROBLEM STATEMENT 2
1.3 PURPOSE OF THE RESEARCH 4
1.3.1 RESEARCH OBJECTIVES 5
1.4 RESEARCH METHODOLOGY 5
1.4.1 RESEARCH DESIGN 5
1.4.2 POPULATION AND SAMPLING 5
1.4.3 TREATMENT MODALITY 7
1.4.3.1 Advanced wound care management 7
1.4.3.2 Currently used wound care management 8
1.4.4 PERIOD OF TREATMENT 8
1.4.5 DATA COLLECTION 9
1.4.6 COST-EFFECTIVENESS 9
1.4.7 ACCEPTABILITY OF TREATMENT METHOD 10
1.4.8 DATAANALYSIS 10
1.4.9 VALIDITY AND RELIABILITY 11
1.5 ETIDCAL CONSIDERATIONS 12
1.5.1 THE RIGHT TO SELF DETERMINATION 12
1.5.2 CONFIDENTIALITY 12
1.5.3 PROTECTION FROM HARM 12
1.5.4 DECLARA nON OF HELSINKI 12
iv
1.5.5 ApPROVAL OF PROTOCOL 12
1.6 TIMING 13
1.7 CONCEPTUALISATION 13
1.8 CONCEPTUAL FRAMEWORK 18
1.8.1 EXPOSITION OF THE CONCEPTUAL FRAMEWORK 18
1.9 DELINEATION OF CHAPTERS 20
1.10 CONCLUSION 20
CHAPTER TWO 21
2.1 INTRODUCTION 22
2.2 DEFINITION 22
2.3 AETIOLOGY 22
2.3.1 EXTRINSIC FACTORS 23
2.3.1.1 Pressure 23
2.3.1.2 Friction 26
2.3.1.3 Shear 26
2.3.1.4 Excessive moisture 28
2.3.2 INTRINSIC FACTORS 28
2.3.2.1 Age 29
2.3.2.2 Immobility and sensory deficits 29
2.3.2.3 Body weight 30
2.3.2.4 Nutrition 30
2.3.2.5 Medication 31
2.3.2.6 Incontinence 31
2.3.2.7 Smoking 32
2.3.2.8 Infection 33
2.3.2.9 Underlying diseases 33
2.3.2.10 Skin condition 33
2.3.2.11 Otherfactors 34
v
2.4 CONCLUSION 35
CHAPTER THREE 36
3.1 INTRODUCTION 37
3.2 PHYSIOLOGY OF WOUND HEALING 37
3.2. ] THE INFLAMMATORY PHASE 39
3.2.2 THE RECONSTRUCTION PHASE 4]
3.2.3 THE EPITHELIALIZATION PHASE 42
3.2.4 MATURATION PHASE 42
3.3 FACTORS INFLUENCING WOUND HEALING 43
3.3. ] SYSTEMIC FACTORS 43
3.3.1.1 Nutrition 44
3.3.] .1.1 Macro-nutrients 44
3.3.].].] (a) Protein 44
3.3.].] . ] (b) Carbohydrates 45
3.3.1.1.1 (c) Fats 45
3.3.1.1.1 (d) Water 45
3.3.1.1.2 Micro-nutrients 45
3.3.1.1.2 (a) Vitamin A ~ 46
3.3.1.1.2 (b) Vitamin B complex 46
3.3.1.1.2 (c) Vitamin C 46
3.3.1.1.2 (d) Vitamin E 47
3.3.1.1.2 (e) Vitamin K 47
3.3.1.1.2 (f) Copper 47
3.3.1.1.2 (g) Iron 48
3.3.1.1.2 (h) Zinc 48
3.3.1.2 Infection 49
3.3.1.3 Medication 49
3.3.] .3.1 Steroid and non-steroid anti-inflammatory drugs 49
3.3.1.3.2 Chemotherapeutic agents 50
3.3.1.3.3 Immunosuppressive drugs 50
vi
3.3.1.3.4 Other 51
3.3.1.4 Radiotherapy/Irradiation 51
3.3.1.5 Oldage 51
3.3.1.6 Underlying systemic conditions 52
3.3.2 LOCAL FACTORS 52
3.3.2.1 Impaired blood supply 52
3.3.2.2 Temperaturefluctuations 54
3.3.2.3 Wound site 55
3.3.2.4 Local infection .' 55
3.3.2.5 Foreign bodies, necrotic tissue, slough and eschar 56
3.3.2.6 Desiccation 56
3.3.2.7 Pressure, friction and shear 57
3.3.2.8 Oxygen tension 57
3.3.2.9 Skin maceration 57
3.4 CONCLUSION 58
CHAPTER FOUR 59
4.1 INTRODUCTION 60
4.2 PRESSURE SORE msx ASSESSMENT 60
4.2.1 NORTON RISK ASSESSMENT SCALE 61
4.2.2 DOUGLAS RlSK ASSESSMENT SCALE 62
4.2.3 WATERLOW RISK ASSESSMENT CARD 62
4.2.4 THE PRESSURE SORE PREDICTION SCALE 63
4.2.5 THE GOSNELL SCALE 63
4.2.6 THE BRADEN SCALE 64
4.3 ASSESSMENT 69
4.3.1 ASSESSMENT OF THE PRESSURE SORE 69
4.3.1.1 Site 70
4.3.1.2 Staging of pressure sores 70
4.3.1.3 Dimensions 73
4.3.1.3 (a) Ruler-based measurements 74
vii
4.3 .1.3 (b) Transparency tracings 75
4.3.1.3 (c) Photographic methods 76
4.3.1.3 (d) Ultrasonic surface scanning 78
4.3.1.3 (e) Casts 78
4.3.1.3Cf) Saline 78
4.3.1.3 (g) Computerized stereo-photogrammetry 79
4.3.1.3 (h) Structured light technique 79
4.3.1.3 Ci) Laser triangulation 80
4.3.1.3. U) Video image analysis 80
4.3 .1.3 (k) Magnetic resonance imaging 80
4.3.1.4 Appearance of the wound bed. 81
4.3.1.5 Exudate 83
4.3.1.6 Odour 84
4.3.1.7 Surrounding skin 85
4.3.1.8 Pain at the wound site 85
4.3.1.9 Clinical signs and symptoms of wound infection 86
4.3.2 ASSESSMENTOFTHEPATIENT 89
4.3.2.1 Physical health and complications 89
4.3.2.2 Nutritional assessment and management 89
4.3.2.3 Psychosocial assessment and management 90
4.4 RELIEVING PRESSlURE 90
4.4.1 BED-BOUNDPATIENTS 91
4.4.2 CHAIR-BOUNDPATIENTS 97
4.5 PRESSURE SORE (WOUND) CARE 98
4.5.1 PROTECTIONOFTHESURROUNDINGSKIN 98
4.5.2 WOUNDCLEANSING 99
4.5.2.1 Woundcleansers 100
4.5.2.1 (a) Cetrimide 101
4.5.2.1 (b) Chlorhexidine 101
4.5.2.1 Cc) Chlorinated solutions 101
4.5.2.1 (d) Hydrogen peroxide 103
4.5.2.1 (e) lodine 103
viii
4.5.2.1 (t) Phenol solutions 104
4.5.2.1 (g) Ringer's lactate 105
4.5.2.1 (h) Sodium chloride 105
4.5.2.1 (i) Water 106
4.5.2.2 Temperature of cleansing solutions 107
4.5.2.3 Cleansing techniques 107
4.5.2.3 (a) Vigorous cleansing techniques 107
4.5 .2.3 (b) Gentle cleansing techniques 108
4.5.3 DEBRIDEMENT 110
4.5.3.1 Sharp (surgical) debridement 11 0
4.5.3.2 Mechanical debridement 111
4.5.3.3 Enzymatic debridement 111
4.5.3.4 Autolytic debridement 112
4.5.3.5 Biological debridement 112
4.5.4 TOPICAL TREATMENT 114
4.5.4.1 Antibiotics 114
4.5.4.2 Dyes 115
4.5.4.3 Sugar 116
4.5.4.4 Essential oils 117
4.5.5 WOUND DRESSINGS 119
4.5.5.1 Semi-permeable adhesive film dressings 120
4.5.5.2 Hydrocolloids (wafers and pastes) 120
4.5.5.3 Hydrogels 122
4.5.5.4 Absorption or filler dressings 124
4.5.5.5 Semipermeable polyurethane foam dressings 126
4.5.5.6 Odour absorbing dressings 129
4.5.5.7 Gauze impregnated dressings (Tulle Gras) 129
4.5.5.8 Iodine-containing dressings 129
4.5.5.9 Gauze dressings 134
4.6 ADJUNCTIVE THERAPY 136
4.7 CONCLUSION : 136
ix
CHAPTER FIVE 137
5.1 INTRODUCTION 138
5.2 COST-MINIMIZATION ANALYSIS 138
5.3 COST-BENEFIT ANALYSIS 139
5.4 COST-UTILITY ANALYSIS 139
5.5 COST-EFFECTIVE ANALYSIS 141
5.6 CONCLUSION 141
CHAPTER SIX 142
6.1 INTRODUCTION 143
6.2 PURPOSE OF THE RESEARCH 143
6.2.1 RESEARCH OBJECTIVES 143
6.3 RESEARCH DESIGN 144
6.4 POPULATION 144
6.4.1 PATIENT RECRUITMENT 145
6.4.2 INCLUSION CRITERIA 145
6.4.3 EXCLUSION CRITERlA 145
6.4.4 WITHDRAWAL PROCEDURE 147
6.5 SAMPLING METHOD 147
6.6 TREATMENT MODALITY 148
6.6.1 ADVANCED WOUND CARE MANAGEMENT. 149
6.6.2 CURRENTLY USED WOUND CARE MANAGEMENT 150
6.6.3 PERIOD OF TREATMENT 151
6.6.4 ADVERSE EVENT 152
6.7 DATA COLLECTION 153
x
6.7.1 THE INSTRUMENTS 154
6.7.1.1 Data collection forms 154
6.7.1.2 Standardised digital wound photography 155
6.7.1.3 Tracing of the wound margins 157
6.7.1.4 Measurements of the wound 157
6.8 DATA ANALYSIS 159
6.8.1 COST ANALYSIS 159
6.8.1.1 Cost of wound care products 160
6.8.1.2 Wound care tariffs 161
6.8.2 COST-EFFECTIVENESS 161
6.8.3 STATISTICAL ANALYSIS 161
6.9 VALIDITY AND RELIABILITY 162
6.9.1 ASSURING CONTENT-RELATED VALIDITY EVIDENCE 162
6.9.2 ADDRESSING MONO-OPERATION BIAS 163
6.9.3 CONSISTENT USE OF INSTRUMENT 163
6.9.4 RANDOMIZATION 164
6.9.5 INCLUSION OF HOMOGENEOUS PATIENTS 164
6.9.6 PILOT STUDY 164
6.9.7 MONITORING 165
6.10 ETIDCAL CONSIDERATIONS 165
6.10.1 THE RIGHT TO SELF DETERMINATION 165
6.10.2 CONFIDENTIALITY 165
6.10.3 PROTECTION FROM HARM 166
6.10.4 DECLARATION OF HELSINKI 166
6.10.5 ApPROVAL OF PROTOCOL 166
6.11 TIMING 166
6.12 CONCLUSION 167
CHAPTER SEVEN 168
7.1 INTRODUCTION 169
xi
7.2 BASE-LINE DATA 169
7.2.1 INITIAL PATIENT INFORMATION CHART 169
7.2.1.1 Gender 172
7.2.1.2 Age 172
7.2.1.3 Allergies 172
7.2.1.4 Body mass index (weight distribution) 172
7.2.1.5 Wound site 173
7.2.2 WEEKLY WOUND ASSESSMENT CHART - WEEK ZERO 173
7.2.2.1 Risk assessment score 178
7.2.2.2 Wound duration 178
7.2.2.3 Wound dimensions 178
7.2.2.4 Pressure sore stage 178
7.2.2.5 Wound exudate, appearance and margins 179
7.2.2.6 Pain 179
7.2.2.7 Factors that may delay wound healing 179
7.2.2.8 Medications used. 180
7.3 PROGRESSION OF THE STUDY 180
7.3.1 WEEKLY COMPARISON OF GROUPS 180
7.3.1.1 Comparison of Braden scores 181
7.3.1.2 Comparison of wound dimensions 182
7.3.1.3 Comparison of wound appearance 183
7.3.2 COMPARISON OF EACH WEEK WITH BASELINE DATA 186
7.3.3 WITHDRAWALS 188
Week one 189
End of week six 189
7.3.4 REASONS FOR WITHDRAWALS 190
7.3.4.1 Death 190
7.3.4.2 Movedfrom the geographical area 191
7.3.4.3 Infection 191
7.3.4.4 Hospitalized 191
7.3.5 HEALERS AND NON-HEALERS 191
7.3.5.1 Healers 192
xii
7.3.5.2 Non-healers 192
7.4 COST ANALYSIS 192
7.4.1 COST ANALYSIS OF PATIENTS THAT COMPLETED THE STUDY 192
7.4.2 COST ANALYSIS OF PATIENTS WHO WERE HEALED 194
7.4.3 COST ANALYSIS OF NON-HEALERS 195
7.5 COST EFFECTIVENESS 196
7.6 ASSESSMENT OF DRESSING ACCEPTABILITY 197
7.6.1 PATIENTS' ASSESSMENT OF DRESSING ACCEPTABILITY 198
7.6.2 CAREGIVER'S ASSESSMENT OF DRESSING ACCEPTABILITY 199
7.6.3 CAREGIVER'S ASSESSMENT OF THE DURABILITY OF DRESSING 200
7.7 CONCLUSION 200
CHAPTER EIGHT 201
8.1 INTRODUCTION 202
8.2 CONCLUSIONS 202
8.2.1 COST-EFFECTIVENESS 202
8.2.2 ACCEPTABILITY OF TREATMENT MODALITlES 203
8.2.2.1 Patients 203
8.2.2.2 Caregiver 203
8.3 LIMITATIONS OF THE STUDY 204
8.4 RECOMMENDATIONS :..205
SUMMARY/ OPSOMMING 207
APPENDIX 1 213
APPENDIX 2 215
APPENDIX 3 223
xiii
APPENDIX 4 225
APPENDIX 5 .................•...................................................................................... 240
APPENDIX 6 247
APPENDIX 7 253
APPENDIX 8 .............•...••••.......................•...•................................••.....•••............. 259
APPENDIX 9 267
APPENDIX 10 273
REFERENCES 275
xiv
~NlDlEj{alF f~GURIES~ GRAPHS AND rAlBllES
Figures
Figure 1.1: Conceptual Framework 18
Figure 2.1: The Iceberg effect 25
Figure 2.2: At risk pressure points in the supine position 27
Figure 2.3: At risk pressure points in the lateral position 27
Figure 2.4: At risk pressure points in the prone position 27
Figure 2.5: At risk pressure points in the sitting position 28
Figure 4.1: Common sites for pressure sores and frequency per site 71
Figure 4.2: The Stirling pressure sore severity scale 72
Figure 4.3: Wong-Baker faces pain rating scale 86
Figure 6.1: Area of an Ellipse 159
Graphs
GRAPH 7.2: Durability of dressings 201
GRAPH 7.1: Average treatment cost of healers 198
Tables
TABLE 3.1: Malfunctioning of body systems: impact on healing 53
TABLE 4.1: Braden risk assessment scale 66
TABLE 4.2: Risk factors which may predispose to wound infections 88
TABLE 4.3: Assessing overlays, mattresses and beds 94
TABLE 4.4: Examples of the use of essential oils in wound care 117
TABLE 4.5: Transparent adhesive film dressings 121
TABLE 4.6: Hydrocolloids 124
TABLE 4.7: Hydrogels 126
TABLE 4.8: Absorption or filler dressings 129
TABLE 4.9: Semipermeable polyurethane foam dressings 131
TABLE 4.10: Odour absorbing dressings 132
TABLE 4.11: Gauze impregnated dressings 133
xv
tables continued ...
TABLE 4.12: Iodine-containing dressings 134
TABLE 4.13: Gauze dressings 136
TABLE 6.1: Coverage of questions in data collection forms 157
TABLE 7.1: Base-line demographic data 171
TABLE 7.2: Base-line pressure sore (wound) assessment data 175
TABLE 7.3: Comparison of Braden risk assessment score 182
TABLE 7.4: Comparison of wound dimensions (area) 183
TABLE 7.5: Comparison of wound appearance 184
TABLE 7.6: Differences in variables between groups per week 187
TABLE 7.7: Withdrawals and healing by week 190
TABLE 7.8: Population (N=58) status at the end of the study period 191
TABLE 7.9: Frequency of dressing changes of completers 194
TABLE 7.10: Comparison of the total treatment cost for all patients 194
TABLE 7.11: Frequency of dressing changes of patients who were
healed 195
TABLE 7.12: Cost to achieve healing 196
TABLE 7.13: Frequency of dressing changes of non-healers 196
TABLE 7.14: Cost of non-healers 197
TABLE 7.15: Patients' assessment of dressing application and removal
..................................................................................................................199
TABLE 7.16: Caregiver's assessment of dressing application and
removal 200
xvi
CHAPTER ONE
~01l1l:rodlLOc1l:0001l,problem statement and methodoloqy
1
1.1 INTRODUCTION
The management of chronic wounds - particularly pressure sores - in
community settings, poses a clinical problem which challenges the patient's
tolerance and the clinician's diligence and ingenuity (Wood, Griffiths & Stoner,
1997:256). Pressure sores can be painful, lead to infection and are associated
with considerable morbidity and increased mortality (patterson & Bennett,
1995:919; Bale, Banks, Hageistein & Harding, 1998:65). Treatment costs of
these wounds are high in terms of resources (Colin, 1995:65; Wood et al.,
1997). However, since there is untold cost in terms of pain and suffering to the
patient, it is impossible to calculate the true cost of pressure sores (Dealey,
1994:87).
1.2 PROBLEM STATEMENT
The literature is virtually flooded with research articles on countless
techniques of pressure sore prevention, nevertheless the occurrence of
pressure sores remains a costly and frustrating health problem (Torrance &
Mayior, 1999:27). In fact, the frustration and desperation which clinicians often
feel is illustrated by a five year study in one locality which showed 72 different
topical treatments applied to pressure sores (Frantz cited in Anthony,
1996:313).
According to James (1997b: 12), patients in a community setting are as
vulnerable to sustaining pressure sores as those in hospital. The same author
identified several community risk factors that are likely to present problems to
skin integrity, namely immobility and unrelieved pressure, malnutrition, age,
incontinence and chronic illness.
2
Due to the increase in the ageing population and the associated higher
degree of morbidity, along with the emphasis on provision of care shifting
towards the earlier discharge of acutely ill patients, it is expected that the
number of patients at risk of developing pressure sores in the community will
increase (Inman & Firth, 1998:515; Glover, 2000:161). This phenomenon will
add to the at-risk-population in the community thereby placing a greater
demand on community resources as a result of an increase in the incidence of
pressure sores.
From the aforementioned, it is clear that the most cost-effective and
acceptable method of wound management is needed to address the problem
of large numbers of pressure sores in the community. A cost-effective method
of wound management implies a method that will result in rapid wound
healing. Research done by Winter (1962:294) has shown that a moist wound
environment promotes re-epithelialisation and healing, thereby supporting
cost-effective wound care management. Even though this landmark study was
published more than 30 years ago, forming the foundation of the researched
base of moist wound healing, many clinicians still use alternative treatment
methods that cause desiccation of the wound-bed and thereby impede the
healing process.
Since wound healing is an intricate and dynamic process, it has been
suggested that no single dressing is suitable for the management of all
wounds, particularly at all stages of the healing process (Bux, 1996:305).
However, the majority of modern dressings are now designed to maintain a
moist environment at the wound interface, providing conditions for rapid
epithelialisation and thereby improved wound healing (Frantz & Gardner,
1994:39; Bux, 1996:305; Dale, 1997:12).
3
Though many of these modern dressings are more expensive than traditional
cellulose-based products, very often wounds dressed with newer products
heal more rapidly than those dressed with conventional materials resulting in
cost savings (Thomas, 1997c\
The choice of dressing or treatment method may be influenced by several
factors - a major one being the cost. Another influence on the choice of
dressing or treatment method is its acceptability to patients and caregivers.
Often patients with chronic wounds and their caregivers have firm views on
the dressings that they will accept based upon prior experience with these or
similar materials (Thomas, 1997c). From the aforementioned, the following
questions arise:
How does the cost-effectiveness of current wound care management
compare with more advanced wound care management and how
acceptable are these treatment modalities to patients with pressure
sores and their caregivers in the community?
1.3 PURPOSE OF THE RESEARCH
The purpose of this study is to: compare current wound care management
methods with a more advanced wound care management method in the
treatment of patients with pressure sores in the community.
All articles retrieved from electronic media such as the Internet and CD-ROMs will not
have page numbers included in the references due to the fact that the printed page
numbers have no relation to the original articles' page numbers. However, hard
copies of the articles are available from the researcher on request.
4
1.3.1 Research objectives
The objectives of this study are to:
~ Compare the cost-effectiveness, with regard to treatment cost and
rate of healing, of current wound care management with advanced
wound care management in the treatment of pressure sores in the
Bloemfontein community of the Free State Province, over a six week
period.
~ Assess the acceptability of these treatment modalities - to patients
with pressure sores and their caregivers in the community over a six
week period - in terms of (i) ease of application, (ii) comfort of the
dressing, (iii) durability of the dressing over the period of application
and (iv) ease of removal.
1.4 RESEARCH METHODOLOGY
1.4.1 Research design
This study will be conducted as a prospective, randomized clinical trial. As
such, an experimental research design will be applied.
1.4.2 Population and sampling
The sample population will be individuals with uninfected pressure sores living
in the Bloemfontein community. Patients will be recruited via referrals from
primary health care clinics, community health care workers, social workers
and other health care professionals practising in the community.
5
Several patient recruitment strategies, as described by Spilker (1991:87), will
be used to increase patient recruitment. They include the following:
o Communicating with colleagues directly, via e-mail and telephone,
requesting referrals.
o Speaking at formal and informal professional meetings requesting
referrals.
o Placing notices in places where colleagues and/or patients will notice.
o Placing advertisements in local newspapers (see Appendix 1).
Once recruited, inclusion and exclusion criteria will be used to enroll patients
into the study.
The following inclusion criteria are to be used:
o Patients in the community aged 18 years or older with a clinically
uninfected Stage2 2, 3 or 4 pressure sore.
o Patients, or their guardians, who give informed consent.
o Patients who are willing and able to comply with the treatment.
The following exclusion criteria are to be used:
o Patients aged younger than 18 years.
o Patients or their guardians, who decline to participate in the study.
o Patients with clinically infected wounds.
o Patients with a Stage 1 pressure sore.
All pressure sores referred to in this study were classified according to the Sterling
Pressure Sore Severity Scale (SPSSS) (see Figure 4.2, p.72).
6
Once enrolled, a patient can withdraw or be withdrawn from the study for the
following reasons:
o at the patient's own request;
o if the patient moves from the geographical area;
o develops a concurrent illness and is unable or unwilling to continue in
the trial;
o develops a wound infection;
o death.
A detailed discussion of the inclusion and exclusion criteria as well as the
withdrawal procedure is provided in Chapter 7.
Sampling will be done by randomly allocating 40 patients with stage 2, 3 or 4
clinically uninfected pressure sores, respectively, into a control and an
experimental group. The Stirling Pressure Sore Severity Scale as described
by Waterlow, (1996:54), will be used as classification system to stage the
pressure sores.
1.4.3 Treatment modality
Two wound care treatment modalities will be used, namely an advanced
wound care management method for patients allocated to the experimental
group, and the currently used management method for patients allocated to
the control group.
1.4.3.1 Advanced wound care management
The wounds will be aseptically cleansed with warm (approximately 37°C)
sterile, physiological saline.
7
Following this, they will be covered with Smith & Nephew™ wound care
products (see Appendix 2 for a list of the Smith & Nephew™ products to be
used in the study as well as instructions for use and contra-indications). The
particular Smith & Nephew™ product (s) used will be dictated by the nature of
each wound. Selection and application of subsequent dressings will also be
adapted to best meet the needs of each wound and its phase of healing.
1.4.3.2 Currently used wound care management
The wounds will be aseptically cleansed and covered with the available and
currently used wound care materials and/or methods as encountered by the
researcher in the community. These materials and/or methods will be listed in
Appendix 3 along with references to the relevant sections in the literature
review where they will be discussed.
1.4.4 Period! of treatment
Each wound will be managed by either the advanced wound care
management method or the currently used wound care management method
for a period of six weeks or until one of the following end points has been
reached:
~ the wound has healed;
~ patient withdraws (see Section 6.4.4);
~ an adverse event occurs by which treatment benefit is unacceptably
inferior to treatment risk (see Chapter 6 for a detailed discussion of the
action to be taken in the case of an adverse event).
8
1.4.5 Data collection
Patients will be clinically assessed at entry week (week 0) and at weekly
intervals thereafter for six consecutive weeks. Data will be collected using four
data collection forms namely:
~ An initial patient information chart.
~ A weekly wound assessment chart that includes the Braden Risk
Assessment Scale (see Table 4.1).
~ A record of dressing changes and products to be used.
~ An assessment of dressing acceptability (see Appendix 4 for copies of
the data collection instruments).
Data related to the following will be collected: the cost-effectiveness (rate of
wound healing related to cost) and acceptability of treatment method. In
addition to the four data collection forms all wounds will be evaluated by
means of photography, wound tracing and measuring of the wound
dimensions (see Sections 6.7.1.2,6.7.1.3 and 6.7.1.4).
1.4.6 cost-effectiveness
The cost-effectiveness of the wound management method will be determined
by assessing the rate of wound healing and the associated cost of the
particular management method.
The rate of wound healing will be determined by comparing the initial and
thereafter weekly clinical assessment and evaluation of the wound size and
appearance.
9
Additionally the following will be used to determine the cost of the advanced
wound care management method in relation to that of the currently used
wound care management method:
~ The duration of the dressing changes, viz. the number of days the
dressing remains in place.
~ The amount and cost of dressing material used over the six-week
period.
~ The time taken to perform each dressing change.
Cost will be calculated from the perspective of a private wound care
practitioner.
1.4./ Acceptability of treatment method
The patient's and the caregiver's acceptance of the management method will
be assessed in terms of the following:
~ ease of application;
~ comfort of the dressing;
~ durability of the dressing over the period of application and
~ ease of removal of the dressing.
1.4.8 Data analysis
Data will be analysed by statisticians of the Department of Biostatistics of the
University of the Orange Free State, using S.A.S. software. Demographic and
baseline information will be summarized by group of patients.
10
Numeric variables will be summarized by means and standard deviations, or
percentiles if the distributions are skew. Categorical variables will be
summarized by frequencies and percentages. The percentage of withdrawals
and adverse events will be compared between the two groups using 95%
confidence intervals for differences in percentages.
This phase of the study will be elaborated on in Chapter 6.
1.4.9 Validity and reliability
The following measures will be taken to increase the validity and reliability of
the study.
Random assignment to experimental and control groups will be used as
design strategies to control extraneous variables. The same strategy will
address lack of equivalence between the experimental and control groups.
Multiple evaluation methods will be used in the weekly assessment of wound
healing to address mono-operation bias as described by Burns and Grove
(1993:269) (see Section 6.7.1).
User errors related to the wound photography will be addressed by the
consistent use of the same camera and operated by the same individual.
The data collection forms will be forwarded to domain experts for comment.
This will be followed by a pilot study to test and improve the data collection
forms and evaluation methods mentioned in Section 1.4.5 thereby assuring
validity of the instrument. Reliability will be supported by the consistent use of
the instrument and evaluation methods.
11
1.5 ETHiCAL CONSIDERATIONS
1.5.1 The right to self determination
Participation in this study will be voluntary. Patients will be enrolled into the
study only with written, informed consent, provided by themselves or their
legal guardians, and where possible in collaboration with their attending
physician(s). Consent forms will be made available in Afrikaans, English and
South-Sotho (see Appendix 5). Patients will also have the right to withdraw
from the study at any time without penalty.
1.5.2 Confidentiality
All patient names will be kept confidential. Similarly all study findings will be
stored and handled in the strictest confidence.
1.5.3 Protection from harm
All patients will be carefully monitored and in case of any adverse event these
patients will be discontinued and managed appropriately (see Chapter 6,
Section 6.6.4).
1.5.4 Declaration of Helsinki
The study will be performed in accordance with the guidelines of the
Declaration of Helsinki (1964) as revised in Somerset West, South Africa in
1996 (see Appendix 6).
1.5.5Approval of protocol
Before commencing the study, the researcher will submit the study protocol to
the Ethics Committee, Faculty of Health Sciences, University of the Orange
Free State, Bloemfontein.
12
The study will not be initiated until the protocol has been approved and a copy
of the ethics approval has been received in which the protocol is mentioned
by name and number.
1.6 TiMING
The study will commence as soon as the Ethics Committee approval has
been obtained. It is expected that the study will commence in May 1999 and
continue uninterruptedly until the required sample size, as specified in Section
1.4.2, has been obtained. The anticipated completion date of the study is
June 2000.
1.7 CONCEPTUALlSATION
The following are operational definitions of concepts used in this study.
~ Acceptability of treatment method - refers to the following elements:
<> comfort of application and removal of the dressing as perceived
by the patient;
e pain associated with the dressing changes as perceived by the
patient;
<> ease of application and removal of the dressing as reported by
the researcher;
e durability of the dressing as reported by the researcher.
13
~ Advanced wound care management method - in this study refers to
the aseptic cleansing of the wound with warm (approximately 37°C)
sterile, physiological saline and subsequently the covering or dressing
of the wound with an appropriate Smith & Nephew™ product (see
Appendix 2 for a list of the Smith & Nephew™ products used in this
study as well as instructions for use and contra-indications).
~ Adverse event - refers to any undesirable clinical occurrence in a
patient whether it is thought to be related to the investigational
product(s) or not (Spilker, 1991:197; European Committee for
Standardization, 1993:4 & Human Subject Protection Committee,
1997).
~ Device related adverse incidents - refer to any undesirable clinical
occurrence in a patient which is thought to be directly related to the
investigational product(s) (Spilker, 1991:197; European Committee for
Standardization, 1993:4; Human Subject Protection Committee, 1997).
~ Community settings - refer to all areas of residence, excluding
hospitals, within the Bloemfontein community which include the
following:
<> all areas within the old municipal boundaries of Bloemfontein;
<> Bainsvlei- and Bloemspruit smallholdings; and
• Mangaung (Van Heerden, 1999).
~ Cost-effectiveness - in this study refers to the simultaneous
measurement of costs and effectiveness of treatment.
14
The cost of treatment (cost of wound treatment method, number of
dressing changes and time taken to perform each dressing change
measured in terms of money) in relation to the effectiveness
(measured in terms of rate of healing or reduction in wound size,
expressed as a percentage) (Spilker, 1991 :302; Robinson, 1993a:672;
Robinson, 1993c:793; Brooks, 1997: 136; Brooks & Semiyen,
1997:492).
~ Currently used wound care management method - refers to the
aseptic cleansing and covering or dressing of the wound with the
available and currently used wound care materials and/or methods as
encountered by the researcher in the community (See Appendix 3).
These materials might include some advanced or modern dressings,
however any Smith & Nephew™ products will be excluded.
~ Extrinsic factors - refer to external factors that contribute to the
development, maintenance and deterioration of a pressure sore. These
factors include pressure, friction, shear and excessive moisture
(Dealey, 1994:84; James, 1997a:8-9).
~ Intrinsic factors - refer to the internal factors that contribute to the
development, maintenance and deterioration of a pressure sore. These
factors include: old age, immobility, sensory deficits, body weight,
nutrition, medication, and incontinence (Dealey, 1994:85-86; James,
1997a:8).
~ Local factors - refer to the factors in and around the wound that
influence the rate of healing. They include impaired blood supply;
temperature fluctuations; wound site; infection; foreign bodies, eschar,
slough, necrotic tissue; desiccation; pressure, friction and sheet;
changes in oxygen tension and skin maceration (Baxter & Mertz,
1992:16; Flanagan, 1997b:30; Brychta, Germann, Gericke, Rietzsch &
Tautenhahn, 1999: 41-42).
15
~ Pressure sore - is defined as a lesion primarily caused by external
factors namely: unrelieved pressure against soft tissue (usually over
bony prominences), shear, friction or moisture or a combination of any
of these and predisposed by certain intrinsic factors (Bridel, 1993:231;
Agency for Health Care Policy and Research [AHCPR], 1994:1;
Brychta eta/., 1999: 81) (see Section 2.2.1 and 2.2.2).
~ Pressure sore management - is the holistic management of the
patient with a pressure sore which includes all aspects namely: intrinsic
and extrinsic factors which contributed to the development,
maintenance and deterioration of the pressure sore; local and systemic
factors which may impede the wound healing process and the method
of pressure sore (wound) treatment.
~ Systemic factors - are factors within or inherent to the body systems
that influence the rate wound healing. They include nutrition, infection,
medication, radiotherapy, old age and underlying conditions such as
diabetes, malignancy, immuno-deficiency and vascular disease
(Dealey, 1994:28-29; Brychta et a/., 1999:38-41).
~ The Stirling Pressure Sore Severity Scale (SPSSS) - is a wound
classification system whereby pressure sores are staged to classify the
degree of tissue damage observed thus providing a more accurate and
detailed wound description. Stages one to four are described as
follows:
Stage 1:
Discoloration of intact skin (light finger pressure applied to the site does
not alter the discoloration).
16
Stage 2:
Partial-thickness skin loss involving damage to epidermis and/or
dermis.
Stage 3:
Full-thickness skin loss involving damage or necrosis of subcutaneous
tissue but not extending to underlying bone, tendon or joint capsule.
Stage 4:
Full-thickness skin loss with extensive destruction and tissue necrosis
extending to underlying bone, tendon or joint capsule (Waterlow,
1996:56).
~ Withdrawals - refers to patients that are withdrawn from the study due
to the following reasons: at the patient's own request; if the patient
moves from the geographical area; developed a concurrent illness and
is unable or unwilling to continue in the trial; developed a wound
infection; death.
~ Wound treatment method - is the method used to treat the pressure
sore or wound. This includes the choice of wound cleanser, method of
cleansing, choice of topical treatment and choice of wound dressing(s).
In this study reference is made to two treatment methods, namely an
advanced wound care management method and the currently used
wound care management method.
17
1.8 CONCEPTUAL FRAMEWo.RK
In figure 1.1 below, the conceptual framework used in this study is delineated.
Extrinsic Factors Wound TreatmentMethods
1
oe
_F_maca_int~te_n~a_nvc~e_~a~n"Tdn~__£;~-(_re~ssnu_r~e~_g_t_o s:r. ,--_sao~re_~t_re:pa_tmt:_e:n_t~em_eCt~ho_di~e_es_::_~_e----,
deterioration
'--
i T
Management of local
and systemic factors
Intrinsic Factors impeding wound
healing
Figure 1.1: Conceptual Framework
1.8.1 Exposition of the conceptual framework
The conceptual framework may be seen as a process initiated with the
presence of factors that contribute to the development of a pressure sore.
These factors are categorized as intrinsic and extrinsic. Intrinsic factors
include: old age, immobility, sensory deficits, body weight, nutrition,
medication, and incontinence. Extrinsic factors include pressure, friction,
shear and excessive moisture. If these factors are not adequately addressed
they will not only contribute to the development of more pressure sores but
will maintain and exacerbate existing pressure sores.
18
Once a pressure sore develops, several factors influence the (wound) healing
process. These are referred to as local and systemic factors that impede
wound healing. Local factors include: impaired blood supply; temperature
fluctuations; wound site; infection; foreign bodies; eschar; slough; necrotic
tissue; desiccation; pressure, friction and shear; changes in oxygen tension
and skin maceration. Systemic factors include nutrition, infection,
medication, radiotherapy, old age and underlying conditions such as diabetes,
malignancy, immuno-deficiency and vascular disease. In order to achieve the
maximum wound healing potential these factors should, where possible, be
counterbalanced.
An additional factor which influences wound healing, either positively or
negatively, is the wound treatment method. The two wound treatment
methods that are compared in this study are the advanced and the currently
used wound care management methods.
The conceptual framework illustrates all the above factors and their
interrelationships as a dynamic process. The anticipated outcome of this
process is a cost-effective and acceptable pressure sore treatment
method.
However, this outcome can only be achieved through a holistic approach,
cognisant of all factors described above.
19
1.9 DELINEATION OF CHAPTERS
IChapter One Introduction, problem statement and methodology
-----
Literature review: Pressure sores: definition and
Chapter Two
aetiology
-~--__._ ._--_ ............... _ ..._-_ ...
Chapter Three Literature review: Healing of pressure sores
I
1------.__ ...._....----
Literature review: Principles of pressure sore
Chapter Four
management
--"'--."
Literature review: Economic evaluation of pressure sore
Chapter Five
management
._---_.-
Chapter Six Research methodology
Chapter Seven Results and discussion
-------
Chapter Eight Conclusions, limitations and recommendations
1.10 CONCLUSION
This study will compare two treatment modalities in the management of
pressure sores in the community and aims to aid wound care practitioners in
selecting a more cost-effective and acceptable method of pressure sore
management.
20
CHAPTER Two
Pressure sores: definition and aetioloqy
21
2.1 INTRODUCTION
In this chapter pressure sores are defined and the aetiology discussed.
2.2 DEFINITION
Pressure sores are defined as lesions primarily caused by external factors,
namely unrelieved pressure against soft tissue (usually over bony
prominences), shear, friction or moisture or a combination of any of these and
predisposed by certain intrinsic factors (Bridei,. 1993:231; Agency for Health
Care Policy and Research [AHCP.R], 1994:1; Brychta et a/., 1999:81) (see
Section 2.3.1 and 2.3.2).
For many years pressure sores were incorrectly termed decubitus ulcers - the
Latin definition of the term decubitus implies lying flat. The term decubitus was
therefore changed to pressure since one can develop a pressure sore while
assuming any body position (Phipps, Cassmeyer, Sands & Lehman,
1995:2348). Thus, the term pressure sore most accurately reflects the
aetiology of the damage.
2.3 AETIOLOGY
Pressure sores are caused by a combination of contributing external
(extrinsic) and internal (intrinsic) risk factors (Dealey, 1994:84; Patterson &
Bennett, 1995:919-920; Lueckenotte, 1996:791; Langemo, 1999). An
overview of these factors will be provided in the following paragraphs.
22
2.3.1 Extrinsic factors
Pressure, shear, friction, and moisture are extern.al risk factors that lead to the
development of pressure sores! However, pressure on soft tissue over bony
prominenees or other hard surfaces is considered the most important
causative factor (Cullum, Deeks, Fletcher, Sheldon & Song, 1995:289;
Perdue, 1995: 66; Lueckenotte, 1996:791).
2.3.1.1 Pressure
It is widely quoted in the literature that when the pressure applied to soft
tissue between a bony prominence and a hard surface (known as interface
pressure) exceeds the normal capillary filling pressure of 32 mmHg, capillary
flow can be obstructed, resulting in hypoperfusion and localized ischaemia
(Torrance, 1983:11; Dealey, 1994:84). However, Kemp and Krouskop
(1994:27) challenge this hypothesis stating that a value of 32 mmHg would
not be a safe estimate of tissue viability since arteriolar capillary pressures as
low as 12 mmHg have been recorded in persons with peripheral vascular
disease. Bridel (1993:233) adds a further argument against this hypothesis
stating that the collagen content of the dermis, which alters with disease
and/or age, will affect the capacity of the dermis to buffer external pressure,
thus the threshold pressure will"vary from individual to individual. Furthermore,
when external pressure is applied to the skin, an autoregulation process
allows internal capillary pressures to rise correspondingly.
This autoregulation process breaks down only in those with normal circulation
when external pressure exceeds diastolic pressure, indicating that the use of
32 mmHg is conservative.
23
Conversely, in patients with increased susceptibility (the elderly or severely
ill) where the autoregulatory mechanism is compromised, occlusion has been
reported when pressures of less than 20 mmHg are applied again indicating
that the use of 32 mmHg is inappropriate.
From these arguments it is apparent that there are wide variations in
individual capacity to resist pressure and the ~se of 32 mmHg as a universal
threshold for estimating tissue viability for all patients, may be inappropriate.
Pressure causing prolonged hypoperfusion can result in a cascade of
hypoxia, acidosis, haemorrhage into the interstitium (non-blanchable
erythema), and accumulation of toxic cellular wastes leading to cell death and
tissue necrosis. With prolonged hypoperfusion, fibrinolytic activity decreases
and leads to fibrin deposition and clotting within blood vessels, which may
further compromise blood flow (patterson & Bennett, 1995:920; Collier,
1999:63).
Several studies have established an inverse relationship between the amount
of time and the amount of pressure necessary to produce pathologic tissue
changes (Maklebust, 1987:363-364).
However, Bridel (1993:235) points out that due to the individual nature of
response to pressure of skin and underlying tissues, pressures of any value
and time periods of any duration need to be considered. Pressure applied to
the epidermis results in the highest pressure in tissues nearest to the bone.
The pressure is dissipated in such a way that a cone-shaped gradient of
pressure exists with the base of the cone on the underlying bony surface
(Baxter & Mertz, 1992:19).
The damage produced by the cone-shaped pressure gradient results in a
pattern of tissue damage described as the iceberg effect (see Figure 2.1,
p.25).
24
Thus, the visible sore at the skin surface fails to reveal the true extent of
tissue damage (Oealey, 1994:84; Miller & Collier, 1997:6; Banks, 1997:506).
Maklebust (1987:365) proposes that although clinical awareness of impending
necrosis occurs only when the skin becomes inflamed, it is most likely that
necrosis of the subcutaneous tissue, fat, and muscle has already occurred
over a surface wider than the apparent area of skin loss.
Common bony prominences susceptibte to pressure sore devetopment are
the sacrum, ischial tuberosity, lateral malleolus, trochanter, and heels (Inman
& Firth, 1998:516). Yet, lueckenotte (1996:791) cautions that any pressure
point is a vulnerable area when pressure is intense and prolonged. Another
important force that acts directly on the epidermis is friction.
Prolonged or repeated pressure
or shear force
1/Apparent extent ofV tissue damageSkin Surface
Banks, 1997:506
Figure 2.1: The Iceberg effect
25
2.3.1.2 Friction
Friction between the skin and an external surface such as bedclothes, linen,
footwear or a prosthetic device results in a loss of the upper layer of the skin -
the stratum corneum. Loss of this protective layer leads to further breakdown,
as more delicate layers of tissue are exposed, thus accelerating the
development of pressure sores (patterson & Bennett, 1995:920).
In some cases restless patients and patients with uncontrollable spasms
develop skin damage from friction. However, according to Dealey (1994:84),
the most common cause of friction is dragging rather than lifting the patient
across the bed.
2.3.1.3 Shear
Shear force results when friction between the skin and a supporting surface
holds the soft tissues in place while gravity pulls the axial skeleton down. An
example of this is when the head or backrest of the bed is raised and the
patient's torso slides down. Tension generated by this motion stretches and
perforates arterioles, which are perpendicular to and supply the dermal layers,
thereby compromising micro-circulation (Crow, 1988:68; Dealey, 1994:84;
Patterson & Bennett, 1995: 920). According to Banks (1997:506) a
combination of friction and shear force is potentially damaging especially to
elderly skin because of the shrinkage of collagen and elastic fibres in the
dermal layer and weakening of the dermal-epidermal junction.
Figures 2.2, 2.3, 2.4 and 2.5, on the following two pages, illustrate some. of
the most common at risk pressure point sites in various positions, as well as
the mechanical forces of friction and shear.
26
The Tissue Viability Society, 1998
Figure 2.2: At risk pressure points in the supine position
Upper•HuInllfUS El•bow
The Tissue Viability Society, 1998
Figure 2.3: At risk pressure points in the lateral position
El•bow
The TISSue Viab~itySociety, 1998
Figure 2.4: At risk pressure points in the prone position
. 27
Friction __ ___,.~..
The Tissue Viability Society, 1998
Figure 2.5: At risk pressure points in the sitting position
2.3.1.4 Excessive moisture
Moisture in itself does not cause pressure sores (Bridel, 1993:235). However,
prolonged exposure to moisture as contained in urine, diarrhoea, perspiration,
and wound drainage, softens the stratum corneum and leads to skin
maceration. Macerated skin loses its integrity, has decreased tensile strength,
is easily damaged, exacerbates the effects of friction, and therefore greatly
increases the risk of pressure sore development. Moist skin will also stick to
bed linen and thus increase the risk of shear damage (Maklebust, 1987:369;
Dealey, 1994:85; Patterson & Bennett, 1995:920).
2.3.2 Intrinsic factors
Although the body is subjected to extrinsic factors on a daHy basis, pressure
sores do not necessarily develop unless certain intrinsic factors are present
28
The following intrinsic risk factors have been identified from the literature and
will be discussed: age, immobility, sensory deficits, body weight, nutrition,
medication, and incontinence.
2.3.2.1 Age
Although pressure sores can occur at any age, there is a correlation between
the ageing process and the incidence of pressure sores (Banks, 1997:507;
Scott, 1998:78). Ageing is associated with thinning of the epidermis,
decreased numbers of dermal blood vessels, loss of dermal elastin (both in
quantity and quality), increased skin permeability, and some muscle atrophy.
The decreasing amounts of collagen fibres stiffen and the immune response
becomes sluggish.
All these age-related changes impair the early warning signs of erythema,
delay crucial early immunologic responses, and thereby increase the
susceptibility of older people to pressure sore development (Torrance,
1983:25; Staas & Cioschi, 1991:539; Dealey, 1994:85; Patterson & Bennett,
1995:920; Bennett & Moody, 1995:31; Lueckenotte, 1996:793; Lewis,
1997:41).
2.3.2.2 Immobility and sensory deficits
Reduced mobility and sensory deficits can affect the ability to relieve pressure
effectively if at all, and have been found to be significant contributory factors
for many patients with pressure sores (Dealey, 1994:86; Maklebust, 1995:47;
Banks, 1997:507; James,1997b:8).
Many conditions such as stroke, arthritis, multiple sclerosis, spinal cord
trauma, head injury, over-sedation, depression and confusion contribute to
immobility (Maklebust, 1987:371).
29
Immobility predisposes to shearing and friction and Bergman-Evans,
Cuddigan and Bergstrom (1994:22) state that immobility and inactivity are
also associated with the development of larger ulcers.
2.3.2.3 Body weight
Patients of low body weight with little subcutaneous fat and poor muscle bulk,
have less protection from pressure at bony prominences. Obese patients
have more fatty padding to cushion underlying tissues and give a more even
distribution of pressure. However, the overweight patient presents more
handling difficulties and shearing force and friction may be special problems
when moving such patients.
Obese patients may also perspire excessively, causing maceration of the skin
which further increases the risk of tissue damage due to shear and friction
(Torrance, 1983:21-22; Dealey, 1994:86; Banks, 1997:507). In addition to
these problems, Armstrong (1998:221) reports that obese patients have
reduced tissue oxygenation and collagen production, which in turn will slow
healing in existing pressure sores.
2.3.2.4 Nutrition
Prospective studies demonstrate that nutritional risk factors for developing
pressure sores are consuming inadequate calories and protein and having a
low serum albumin level of less than 30-35g/1 (Colburn, 1990:63; Phipps et al.,
1995:2351; Lueckenotte, 1996:793). According to James (1997a:8) protein
deficiency may be further exacerbated if a pressure sore forms, as protein is
lost via the wound exudate. Factors affecting nutritional intake are dental
problems, underlying disease, depression, isolation or grief.
30
Additional risk factors which may afféct the nutritional intake of patients,
particularly in a community setting, are lack of money, impaired physical
ability leading to a reduced ability to prepare food, lack of carer support and
confusion.
In a retrospective community-based study Bergquist and Frantz (1999) found
anaemia, as a measure of nutrition, predictive of pressure sore development.
Breslaw & Bergstrom (1994) and Lewis (1996:484) state that although there is
some evidence that vitamin C, provided at levels exceeding the RDA, may
improve healing of pressure sores, there is no strong evidence that
biochemical or dietary deficiencies of zinc or vitamins A, C or E are major risk
factors for the development of pressure sores.
2.3.2.5 Medication
Steroids, anti-inflammatory medication, strong analgesia, sedatives, beta-
blockers and cytotoxic drugs can increase the risk of pressure damage by
reducing skin integrity, mobility, sensation or appetite. Some drugs may cause
diarrhea or urinary incontinence, such as diuretics, antibiotics and laxatives
and thereby add to the risk of pressure sore development (Dealey, 1994:87;
Bennett & Moody, 1995:71; Banks, 1997:507).
2.3.2.6 Incontinence
Studies have found a strong correlation between incontinence and pressure
sore development. Prolonged contact with urine and/or faeces results in
maceration of the stratum corneum and may destroy the protective acid-base
mantle. Normal, healthy skin maintains an acid pH of 4,5 to 5,5, which
protects it from microbial colonization. Freshly voided urine has a pH of 6.
31
However, when exposed to air it becomes more alkaline often rising to 13
thereby increasing the risk of damage to the epidermis (CasseIl, 1986:36;
Patterson & Bennett, 1995:920).
It has been suggested that faecal incontinence may be a more important risk
factor than urinary incontinence (Allman., Laprade, Noel, Walker, Moorer, Dear
& Smith, 1986:340). In addition to skin maceration associated with faecal
incontinence, the bacterial ureases from faecal soiling can split urea to
ammonia, also causing the pH of the skin to rise and become increasingly
permeable, thus making the skin more susceptible to injury. Additionally,
chemical irritants contained in faeces, such as proteolytic enzymes, may
irritate the skin and directly injure epithelial cells in a relatively short period of
time. Furthermore, the same authors propose that once its protective barrier is
destroyed, the compromised skin places an individual at risk of developing a
local infection that could ultimately lead to a systemic infection.
2.3.2.7 Smoking
Smoking causes vasoconstriction, which in turn reduces tissue perfusion.
Additionally, carbon monoxide inhaled during smoking binds to haemoglobin
with an affinity greater than 200 times that of oxygen. The presence of
carboxyhaemoglobin shifts the oxygen dissociation curve to the left thereby
exacerbating poor tissue oxygenation as less oxygen can be used. This
results in impaired metabolism and slower healing (Towier, 2000: 101).
Dealey (1994:39) cited a 1992 report by Siana, Frankild and Gottrup that
nicotine affected macrophage activity and reduced epithelialization and wound
contraction. Smoking may result "in loss of appetite and smokers have been
found to be deficient in vitamins B1, B6, B12and C. These vitamin deficiencies
has been shown to interfere with wound healing (Dealey, 1994:44; Banks,
1997:507). From the above it may be concluded that the deleterious effects of
smoking contribute significantly to the risk of pressure sore development.
32
2.3.2.8 Infection
Systemic infection may cause pyrexia, increased metabolism, excessive
perspiration and tissue breakdown thereby increasing the risk for pressure
sore development significantly (Maklebust, 1987:370; Phillips, 1997:36).
2.3.2.9 Underlying diseases
Many underlying conditions or diseases can cause immobility, loss of
sensation, muscle spasms, excessive perspiration and incontinence and
therefore predispose patients to develop pressure sores.
Disorders which may predispose patients include diabetes, arthritis,
Alzheimer's disease, Parkinson's disease, multiple sclerosis, carcinoma and
gastrointestinal, pancreatic, liver and renal problems (Allman et et., 1986:337;
Dealey, 1994:85-87; Patterson & Bennett, 1995:920; James, 1997b:14;
Banks, 1997:507).
2.3.2.10 Skin condition
Ageing or the use of long-term high-dose steroids may result in "tissue paper"
skin that is particularly susceptible to breakdown. Oedematous skin is also at
risk of over-stretching due to excessive fluid in the tissues, resulting in
damage to the micro-circulation, reduced oxygen supply and impaired
removal of metabolic by-products which predispose to tissue damage (Banks,
1997:507; Arao, Obata, Shimada & Hagisawa, 1999:1). In addition research
has linked dry, flaky or scaling skin to an increased incidence of pressure
sores (Skewes, 1996:33).
33
2.3.2.11 Other factors
Banks (1997:507) reported that state of consciousness, pain, psychological
and socio-economic factors may also be contributory factors. Emotional stress
leads to release of cortisol from the adrenal glarids. The effects of cortisol are
believed to alter the skin's ability to absorb mechanical loads, such as
pressure. Cortisone may also affect cellular metabolism between capillary
beds and cells, making the skin vulnerable to breakdown and poor healing
(Maklebust, 1987:370; Lueckenotte, 1996:793). According to Song (1999:8)
radiation therapy may similarly compromise the skin and thereby increase its
susceptibility to tissue damage.
Research by Bergquist and Frantz (1999) to identify risk factors related to the
development of pressure sores, revealed that when an adult child was the
primary caregiver, subjects were 5,8 times more likely to develop a pressure
sore. Yet, the mechanism by which the adult child as primary caregiver was
associated with pressure sore development was unclear.
The same researchers reported that being male increased the risk of
developing a pressure sore by 86%. Again, the mechanism by which the male
gender was associated with pressure sore development was unclear.
However, the findings of this study were consistent with two studies that used
large data sets to explore the risk fattors associated with pressure sore
development (Specter, Kapp, Tucker & Sternberg; Specter cited in Bergquist
& Frantz, 1999).
34
2.4 CONCLUSION
From the preceding paragraphs it is clear that apart from the primary external
mechanical forces, there are multiple additional external and internal factors
that contribute and/or predispose to the development of pressure sores.
35
CHAPTER THREE
Healing of pressure sores
36
3.1 INTRODUCTION
In this chapter the healing of pressure sores will be discussed with reference
to the physiology of wound healing and the factors that influence the healing
process.
3.2 PHYS~OLOGY OF WOUND HEAUNG
Wound healing is a dynamic and highly complex process, which would require
a lengthy detailed explanation in order to cover all known physiological
aspects. Scholars have written many in-depth analyses of this intricate
process and it is not the intention of this researcher to describe it to the extent
found elsewhere. However, it is important and necessary that the wound care
practitioner has a good understanding of the basic physiological processes
involved in wound healing for several reasons namely:
~ Recognition of the different stages or phases of wound healing allow
the practitioner to select appropriate dressings.
~ Knowledge and understanding of the normal physiology enables the
practitioner to recognize the abnormal.
~ Knowledge and understanding of the requirements of the healing
process means that appropriate nutrition can, where possible, be given
to the patient (Dealey, 1994:1).
Therefore, in the light of the above, a brief overview of the basic physiological
processes of wound healing will be explicated in the following paragraphs.
37
In the management of wound healing, wounds are often described as healing
by first and second intention. Healing by first or primary intention occurs when
there is no tissue loss and the skin edges .are held in apposition to each other,
such as sutured traumatic or surgical wounds. Granulation tissue is not
visible, scar formation is minimal and healing is usually rapid.
Healing by secondary intention occurs in large wounds -' such as chronic
wounds, for example pressure sores and leg ulcers - with considerable tissue
loss. Natural healing occurs by the formation of granulation tissue, which fills
the cavity. The healing process takes longer and results in more scarring.
Healing by first and second intention was first described as early as 350 B.C.
by Hippocrates. In addition wounds labelled as open and closed are the same
as healing by second and first intention respectively (Tudor & Gupta, 1992:70;
Dealey, 1994:2; Miller & Collier, 1997:3; Banks, 1998e:265).
For the sake of discussion the healing process must be divided into phases.
Some authors, such as Sieggreen. (1987:439), Cooper (1990: 170), Tudor and
Gupta (1992:70), Konstantinides and Lehmann (1993:25) and Frantz and
Gardner (1994:35), separate the healing trajectory into three phases. Others
separate the healing process into four or more phases depending on their
perspective (Dealey, 1994:1; Banks, 1998e:265). Similarly the terms used to
describe the phases also differ from author to author. However, the events
described within each phase allow one to identify the phase being addressed.
Using the four-phase approach, as described by Banks (1998e:265), the
healing trajectory may be divided into the inJ/ammatory phase, the
reconstruction phase, the epithelialization phase and the maturation
phase. Although the phases will be discussed separately, different steps of
each phase may occur simultaneously.
38
3.2.1 The inflammatory phase
Inflammation is an important part of the body's defence mechanism. It is a
non-specific response to tissue damage and/or infection and is an essential
part of the healing process. The onset of inflammation occurs immediately
after injury, normally lasting three to five days (Sieggreen, 1987:440; Cooper,
1990:170 -171; Tudor & Gupta, 1992:72; Konstantinides & Lehman, 1993:25;
Dealey, 1994:2).
Vascular and cellular responses occur immediately after injury in an attempt
to wall the wound off from the external environment. Platelets activated as a
result of vessel wall injury, aggregate and blood coagulation is initiated.
Damage to the micro-circulation at the area of injury causes vasoconstriction
of vessels in an attempt to control bleeding and to protect against increased
exposure to bacterial contamination. During the initial period of
vasoconstriction, leukocytes, erythrocytes and platelets line the vessel wall.
This initial reaction is brief and lasts from 5 to 10 minutes (Sieggreen,
1987:440; Cooper, 1990: 170). The complement system consisting of proteins
that normally lie dormant in the blood, the interstitial fluid and on the mucosal
surfaces, is also activated. Activation of this system by microbes or antigen-
antibody complexes, causes three activities: vasodilatation of capillaries;
chemotaxis (unidirectional migration) of phagocytic leukocytes into the injured
region; and opsonization (coating) of the microbes for effective phagocytosis
(Cooper, 1990: 170). Bradykinin and histamine are also released from injured
tissues, causing vasodilation so that 10 to 30 minutes after injury the vessels
in and around the wound dilate and capillary permeability is increased
(Sieggreen, 1987:440; Tilbury, 1991 a:30).
39
Fluid, protein, enzymes and cells normally found in the intravascular
compartment, move through gaps in the capillary 'walls (diapedesis) into the
extracellular space causing oedema and erythema - hence manifesting the
typical redness, heat, swelling, pain and loss of function associated with the
inflammatory response (Cooper, 1990:171; Tudor & Gupta, 1992:72; Dealey,
1994:2; Harding, Bale & Assenheimer, 1997).
Two types of leukocytes, polymorphonuclear (PMNs) granulocytes and
mononuclear agranulocytes, enter the wound initially, thereby providing it with
resistance to infection (Sieggreen, 1987:440, Cooper, 1990:171; Tudor &
Gupta, 1992:72). The PMNs begin to digest bacteria that are present.
However, their life span is very short and after two to three days they become
part of the wound exudate. Mononuclear agranulocytes, with a longer life
span, having entered the wound bed with the PMNs, begin their function.
Once in the tissues they give rise to macrophages. These macrophages are
larger than neutrophils and are therefore able to phagocytose larger particles,
such as necrotic debris, dead neutrophils as well as bacteria (Konstantinides
& Lehmann, 1993:25). Macrophages also produce a variety of substances
that stimulate healing, including:
~ Transforming growth factors (TGF-a, TGF-~) promote the formation of
new tissue and influence angiogenesis and neovascularisation.
~ Tumor necrosing factor facilitates the breakdown of necrotic tissue and
tumors, stimulates angiogenesis and growth of new tissues.
~ Fibroblast growth factor (FGF-1 and FGF-2) stimulates angiogenesis
and the production of fibroblasts.
~ Prostaglandins promote the inflammatory response.
~ Complement factors mark invading foreign bodies.
~ Platelet-derived growth factor (PDGF) is involved in initiating the
inflammatory phase of healing (Flanagan, 1997b:24, Gill, 1998:411,
412; Graham, 1998:465).
40
Considerable resources of energy. and nutrients are required during this
phase. If this phase is prolonged by irritation of the wound - such as infection,
foreign bodies or damage caused by the dressing - it can delay healing and
cause the patient to become debilitated'(Dealey, 1994:3; Banks, 1998e:265).
3,2.2 The reconstruction phase
Macraphages play an important role in bridging the inflammation and
reconstruction phases. They provide growth factors, which attract fibroblasts
to the wound, stimulate fibroblast division and collagen production (Tudor &
Gupta, 1992:72). Fibroblast activity is dependent on local oxygen supply.
Poorly vascularized tissues will therefore not heal well. Thus, macraphages
assist in enhancing fibroblast activity by stimulating angiogenesis (formation
of a new capillary network) capable of supplying oxygen to the wound
(Sieggreen, 1987:442; Ehrlich, 1998). Relatively low levels of oxygen at the
wound surface encourage the macraphages to produce angiogenesis factor,
which in turn instigates the process of neo-angiogenesis (Dealey, 1994:4;
Banks, 1998e:265).
Undamaged capillaries beneath the wound grow towards the wound surface,
loop back and give a granular appearance to the wound surface. The loops
form a network within the wound supplying oxygen and nutrients. In wounds
healing by secondary intention, such as pressure sores, this granulation
tissue is clearly visible. It consists of a dense array of macrophages,
fibroblasts, capillary buds and loops in a matrix of fibronectin, collagen and
hyaluronic acid. Certain specialized fibroblasts - myofibroblasts - have a
contractile apparatus, which causes contraction of the wound around the fifth
or sixth day. This contraction reduces the surface area of open wounds.
However, according to Flanagan (1997b:25) the. amount of contraction
possible in a particular wound depends on its anatomical location and the
degree of mobility of the surrounding tissue.
41
The number of macrophages and fibroblasts gradually reduces as the wound
fills with new tissue and a capillary network is established (Cooper, 1990:172;
Tilbury, 1991a:30; Dealey, 1994:5; Harding, Bale & Assenheimer, 1997;
Banks, 1998e:265).
3.2.3 The epithelialization phase
In open wounds, such as pressure sores, this phase cannot commence until
the wound cavity is sufficiently filled with granulation tissue. However, in
closed wounds this phase may commence as early as the second day post-
injury (Dealey, 1994:5). Moisture is required to allow cells to advance over the
wound bed, viz. epithelialization (Winter, 1962:293; Harding, 1996a:46). The
squamous cells at the wound margins and around hair follicle remnants
proliferate and migrate over the wound surface in a "leap-frog" fashion. This
leap-frogging process involves a cell moving two or three cell lengths before
stopping, while other cells are coming up from behind to continue the process
(Garrett, 1998:358). When advancing epithelial cells from opposing wound
borders meet, either at the centre of the wound or at the margin, the process
of cellular movement appears to cease. Garret (1997:177) refers to this
process as contact inhibition as it prevents further cell movement. According
to Sieggreen (1987:440) and Banks (1998e:265) epithelialization also
provides a waterproof protective covering against loss of fluids and entry of
bacteria to the newly repaired wound.
3.2.4 MatUlration phase
During this phase, also known as the remodelling phase, which begins on
about day 21 after injury and may extend to a year or two post-injury, the
wound matures and tensile strength increases (Sieggreen, 1987:442; Cooper,
1990:173; Dealey, 1994:5; Banks, 1998e:265). The wound becomes less
vascularized as there is a reduced need to bring cells to the wound site.
42
Injury alters the symmetry of healthy tissue and when new collagen is initially
laid down, the pattern is random and disordered (Tudor & Gupta, 1992:72).
During this phase of healing these randomly arranged collagen fibres are re-
organized or remodelled to lie at right angles to the wound margins thereby
providing greater overall strength (Tilbury, 1991a:31; Frantz & Gardner,
1994:36). Cooper (1990:174) points out that if alterations occur in the
remodelling and cross linking of collagen during this phase, complications
such as contractures, adhesions and even obstruction of tube-like organs (for
example the bowel and ureters) may occur. The scar tissue gradually grows
smoother and its colour fades. This may take a considerable period of time
and regardless of how well collagen realigns itself, the full tensile strength of
normal uninjured tissue, may not be achieved (Konstantinides & Lehmann,
1993:27; Dealey, 1994:5; Banks, 1998e:265).
3.3 FACTORS INFLUENCiNG WOUND HEALING
The healing process, as described above, is greatly influenced by multiple
factors. The successful management of any wound requires the identification
of any and all factors that may impede healing and where possible,
interventions to address or rectify these factors. The following systemic and
local factors have been identified from the literature and will be discussed.
3.3.1 Systemic factors
,/~/
-./
The systemic factors, which may affect wound healing, include nutrition,
infection, medication, radiotherapy, old age and underlying conditions such as
diabetes, malignancy, immuno-deficiency and vascular disease.
43
3.3.1.1 Nutrition .
In the following paragraphs several important macro- and micro-nutrients,
their role in the wound healing process and the results of their deficiency, will
be discussed.
3.3.1.1.1 Macro-nutrients
Relevant macro-nutrients include protein, carbohydrates, fats and water.
3.3.1.1.1 (a) Protein
Protein, as a fundamental requirement in the healing process, assists in neo-
vascularization, fibroblast proliferation, collagen synthesis, lymph formation
and wound remodeling. It is also associated with collagen and proteoglycan
synthesis (Silane, 1992:42; Dealey, 1994:40; Partridge, 1998:351).
Protein deficiency decreases the body's resistance to infection as it alters
antibody response time and limits leukocyte phagocytic capabilities. The
inflammatory process is prolonged and fibroplasia impaired. Additionally,
collagen synthesis is impaired and macrophage production decreased. An
indicator of visceral protein status is serum albumin levels. Hypo-albuminia
«32 gii) promotes generalized oedema, which in turn slows oxygen diffusion
and metabolic transport mechanisms from the capillaries and cell membrane
(Bobel, 1987:380; Konstantinides & Lehmann, 1993:26-29; Lewis, 1998:31;
Banks, 1998f:319).
44
3.3.1.1.1 (b) Carbohydrates
Carbohydrates aid in cell proliferation and the phagocytic activity of
leukocytes to prepare wounds for fibroplasia. They are needed for cellular
energy and associated with collagen and proteoglycan synthesis.
Carbohydrate deficiency decreases resistance to infection and impairs
collagen synthesis (Maklebust, 1987:369; Silane, 1992:42; Konstantinides &
Lehmann, 1993:26; Dealey, 1994:40; Banks, 1998f:319).
3.3.1.1.1 (c) Fats
Fat (fatty acids) as a source of cellular energy, is required for the normal
functioning of cell membranes and promotes cell synthesis. A deficiency of
this nutrient may inhibit tissue repair (McLaren, 1992:139; Dealey, 1994:40;
Flanagan, 1997b:33; Banks, 1998f:319).
3.3.1.1.1 (d) Water
Water constitutes 65-70% of the total body weight and is the medium in which
almost all metabolic processes occur. Water is therefore considered to be the
most important nutrient of all and essential to life. Loss of water or
dehydration results in electrolyte imbalance, impaired cellular function and
subsequently delayed wound healing (Barker, 1991:26; Flanagan, 1997b:31).
3.3.1.1.2 Micro-nutrients
Relevant micro-nutrients include vitamins A, B, C, E and K as well as the
minerals copper, iron and zinc.
45
3.3.1.1.2 (a) Vitamin A
According to Konstantinides and Lehmann (1993:26), vitamin A is a co-factor
in collagen synthesis and cross-linkage. It is essential for the stimulation of
fibroplasia and epithelialization (Frantz & Gardner, 1994:41). Furthermore, it
counteracts the anti-inflammatory effects of steroids on cell membranes. A
shortage leads to altered collagen synthesis and cross-linking between fibers.
This results in a decreased rate of epithelialization in wound closure (Oumas,
1994:3; Dealey, 1994:40).
3.3.1.1.2 (b) Vitamin B complex
Vitamin B complex - including pyridoxine, riboflavin and thiamin - contribute to
antibody and white blood cell formation; are eo-factors in cellular development
and promote enzyme activity necessary for the metabolism of proteins, fats
and carbohydrates. Deficiency results in decreased resistance to infection
(McLaren, 1992:142; Konstantinides & Lehmann, 1993:26; Dealey, 1994:40;
Banks 1998f:319).
3.3.1.1.2 (c) Vitamin C
Lewis (1998:32) describes Vitamin C as a co-factor for the enzyme collagen
prolyl hydroxylase, which hydroxylates peptide-bound proline on proto-
collagen to hydroxyproline. This is used in the formation of the triple helix of
collagen. Konstantinides and Lehmann (1993:26) state that vitamin C is
essential for neutrophil superoxide production and bacterial killing. It also
improves capillary formation and decreases capillary fragility.
46
Vitamin C deficiency decreases the chemotaxis of neutrophils and monocytes;
alters tensile strength; increases capillary fragility; impairs local antibacterial
defences and increases the tendency for dehiscence of newly formed tissue
(Konstantinides & Lehmann, 1993:26; Oumas, 1994:3; Dealey, 1994:40;
Frantz & Gardner, 1994:41; Banks, 1998f:319). According to Lewis (1998:32)
the emerging role of vitamin C as a scavenger of oxygen free radicals may
further enhance its importance in wound healing, as this appears to be a
process that stimulates healing.
3.3.1.1.2 (d) Vitamin E
Vitamin E prevents lipid peroxidation of poly-unsaturated fatty acids in cell
membranes by oxygen free radicals and hence has an important protective
role in anti-oxidant defence and wound healing (Barker, 1991:31; McLaren,
1992:142).
3.3.1.1.2 (e) Vitamin K
Vitamin K plays an essential role in coagulation. Deficiency of this vitamin
results in an increased risk of haemorrhage and haematoma formation
(Silane, 1992:41; Konstantinides & Lehmann, 1993:27; Banks, 1998f:319).
3.3.1.1.2 (f) Copper
Copper is an intrinsic part in the oxidase system that aids in collagen cross-
linkage and indirectly influences wound healing via the stimulation of
erythropoiesis. Even though deficiency is rare, it may result in decreased
collagen synthesis, anaemia and skeletal demineralisation (Barker, 1991:24;
McLaren, 1992:141; Oumas, 1994:5).
47
3.3.1.1.2 (g) Iron
Iron is vital to red blood cell function because it enables the transport of
oxygen. Iron deficiency reduces the oxygen carrying capacity of blood, results
in anaemia increasing the risk of local tissue ischaemia; impairs tensile
strength and collagen cross-linkage (Bobel, 1987:382; Silane, 1992:42;
Oumas, 1994:4; Oealey, 1994:46; Banks, 1998f:319).
3.3.1.1.2 (h) Zinc
Zinc is considered to be a critical element in protein synthesis and tissue
repair (Silane, 1992:42 and Hampton, 1997:5). Konstantinides and Lehmann
(1993:27) describe zinc as a co-factor in numerous enzyme systems involved
in cellular proliferation and cell membrane stabilization. Zinc deficiency
therefore exerts a considerable impact on all stages of healing resulting in a
reduced epithelialization rate; decreased collagen synthesis; reduced rate of
gain in wound strength and decreased synthesis of retinal binding protein
(Melaren, 1992:141; Oumas, 1994:4).
Lewis (1998:483) points out that, like vitamin C, zinc is a scavenger of free
radicals, a process that may aid healing. However, the same author states
that even though zinc therapy has been shown to be beneficial in patients with
poorly healing surgical wounds, most studies have not proved consistent and
it is now known that there is no beneficial effect to supplementing zinc in
patients where serum zinc concentrations are normal.
Optimum wound healing depends not only upon the adequate intake of the
above-mentioned nutrients, but also upon their adequate absorption.
48
3.3.1.2 Infection
Systemic infection has a detrimental effect on healing, as the wound has to
compete with any infection for leukocytes, oxygen and essential nutrients.
Wound healing may not take place until after the body has dealt with the
infection (Oealey, 1994:28). Furthermore, systemic infection can cause
increased body temperature, excessive perspiration, increased metabolism
and tissue breakdown, all of which may prolong the inflammatory stage of
wound healing (Banks, 1997:507). A recent study carried out by Kramer and
Kearney (2000) confirmed that increased body temperature due to local or
systemic infection processes is associated with poorer wound healing.
3.3.1.3 Medication
Oumas (1994:5) state that almost all medication has an influence on healing,
either directly or indirectly. However, according to the literature the categories
of medication that have the most deleterious effect on wound healing are
steroid and non-steroid anti-inflammatory drugs, chemotherapeutic agents
and immunosuppressive drugs.
3.3.1.3.1 Steroid and non-steroid anti-inflammatory druqs
The administration of steroids mimics and exacerbates the ageing process
and leads to a reduction in the collagen content of the skin. It slows the rate of
epithelialization and new vessel growth, thereby decreasing the tensile
strength of newly closed wounds and inhibiting wound contraction (Zederfeldt,
Jacobsson & Ahonen, 1986:14; Hastings, 1993:70; Bridel, 1993:236; Oealey,
1994:47; Bennett & Moody, 1995:28; Banks, 1997:507).
49
However, Si lane (1992:44) and Oealey (1994:47) state that vitamin A
supplementation may help offset these adverse effects. Anstead (1998) adds
that even though vitamin A restores the inflammatory response and promotes
epithelialization and the synthesis of collagen, it does not reverse the
detrimental effects of glucocorticoids on wound contraction and infection.
Non-steroid anti-inflammatory drugs such as aspirin may decrease the tensile
strength at the wound margin and delay the healing process (Oumas, 1994:6;
Bennett & Moody, 1995:28; Johnson, 1995:279).
3.3.1.3.2 Chemotherapeutic agents
These drugs inhibit DNA/RNA synthesis, suppress protein synthesis, inhibit
mitosis and delay fibroblast proliferation, all of which contribute to decreased
collagen synthesis (Zederfeldt, Jacobsson & Ahonen, 1986: 14; Oumas,
1994:6). These effects result in an increased risk of infection, and in
granulating wounds, less exudate, granulation tissue and slower rates of
contraction (Hastings, 1993:70; Song, 1999:8).
3.3.1.3.3 Immunosuppressive drugs
These agents significantly interfere with the ability of the immune system to
respond to antigenie stimulation by inhibiting cellular and humoral immunity.
Immunologic deficiency impairs many aspects of the inflammatory phase of
healing such as macrophage functioning. It also predisposes to infection and
. therefore negatively affects wound healing (Anderson & Anderson, 1990:455;
Silane, 1992:44; Bennett & Moody, 1995:72).
50
3.3.1.3.4 Other
Other medications that may delay healing include drugs such as beta-
blockers due to their effect in increasing peripheral vascular resistance
(Hastings, 1993:70; Hofman, 1997:53). Anticoagulants and phenotoin may act
on the healing process in ways similar to glucocorticoid action (Silane,
1992:44).
3.3.1.4 Radiotherapyllrradiation
Local irradiation impairs wound healing by depleting dermal fibroblasts and
decreasing the proliferative potential of endothelium, whereas total body
irradiation depresses bone marrow-derived elements, virtually eliminating
wound macrophages. Furthermore the tissue changes associated with
irradiation are related to the cumulative dose of treatment. High doses may
lead to vessel narrowing and reduced blood flow, causing a delay in wound
healing (Hastings, 1993:70; Dealey, 1994:54; Cherry, Hughes, Kingsnorth &
Arnold, 1995:20; Bennett & Moody, 1995:131; Song, 1999:8).
3.3.1.5 Old age
Studies carried out on animals and humans suggest that ageing is associated
with decreased inflammatory and proliferative responses, delayed
angiogenesis, delayed remodelling and slower re-epithelialization. A
significantly higher incidence of wound infection has also been found in
patients over the age of 55 years (Dealey, 1994:29; Desai, 1997:237).
~o~ 51
3.3.1.6 Underlying systemic conditions
The presence of specific medical disorders has a significant influence on
healing. These conditions include diabetes mellitus, cardiovascular and
respiratory diseases, renal failure as well as disorders of the digestive,
nervous and immune systems (Sieggreen, 1987:443; Cooper, 1990:175;
Silane, 1992:41; Hastings 1993:72; Dealey, 1994:42-43; Banks, 1997: 507).
A detailed discussion of these conditions and how they adversely affect the
healing process falls beyond the purpose of this review. However, since
successful wound management requires a holistic approach to, and
comprehensive assessment of the patient, which includes consideration of all
factors that may impede wound healing, a brief summary of how
malfunctioning body systems impact on healing is provided in Table 3.1 (see
p.53).
3.3.2 Local factors
Local factors that influence the rate of healing include impaired blood supply;
temperature fluctuations; wound site; infection; foreign bodies, eschar, slough,
necrotic tissue; desiccation; pressure, friction and shear; changes in oxygen
tension and skin maceration (Baxter & Mertz, 1992:16; Flanagan, 1997b: 30).
3.3.2.1 Impaired blood supply
Disturbances to the peripheral blood supply will reduce tissue perfusion
limiting the local supply of oxygen and other nutrients required for tissue
repair (Flanagan, 1997b:30).
52
TABLE 3.1: Malfunctioning of body systems: impact on healing
Body System Impact on healing
Respiratory system ~ Impairs oxygenation resulting in decreased blood
oxygen.
Circulatory system ~ Arterial and venous insufficiency results in poor
circulation to the wound site, causing inadequate
tissue oxygenation and nutrition as well as impaired
clearance of cellular waste.
~ Anaemia causes a reduction in the oxygen-carrying
capacity of the blood, resulting in inadequate tissue
oxygenation.
Digestive system. ~ Malnutrition and/or malabsorption may lead to protein,
calorie, vitamin and mineral deficiencies.
Excretory system ~ Incontinence and/or renal failure may cause skin
irritating moisture/chemicals, increased susceptibility
to infection, faulty collagen deposition, and increased
levels of nitrogenous breakdown products.
Nervous system ~ Impaired sensation results in no pain signals to warn
of damage.
~ Impaired movement may result in excessive pressure
from remaining too long in one position, resulting in
pressure sores.
~ Impaired central nervous system due to drug therapy,
narcotics and sedatives may decrease awareness.
Immune system ~ Immune deficiency increases susceptibility to infection
and may result in lack of elements necessary for the
inflammatory phase.
Endocrine system ~ Diabetes results in the inability to metabolize glucose
which leads to basement membrane thickening and
increased levels of sorbitol, causing micro-circulatory
impairment, peripheral neuropathy, increased
susceptibility to infection and impairment of the
inflammatory response.
Table 3.1 continues ...
53
TABLE 3.1 Continued ...
Body System Impact on healing
Psychological ~ Anxiety may be related to dermatological conditions.
system ~ Stress causes the release of adrenaline and an
increased secretion of adrenocorticotrophic hormone
(ACTH), which stimulates the production of adrenal
cortex hormones. ACTH regulates the production of
glucocorticoids, which cause a reduction in the
mobility of granulocytes and macrophages, impeding
their migration to the wound. This effectively
suppresses the immune system and reduces the
inflammatory response.
~ Drug, as well as alcohol and nicotine abuse cause
vascular injury (arteriosclerosis and perfusion
abnormalities). This group of patients is often
malnourished with reduced immune responses.
~ Patients with dementia or self-harming tendencies can
be uncooperative and non-compliant.
(Cooper, 1990:175; Silane, 1992:41-46; Flanagan, 1997b:31-32; Sllhl, 1998:5;
Partridge, 1998:350; Brychta et al., 1999:41)
3.3.2.2 Temperature fluctuations
A fall of two degrees Celsius at the wound interface is enough to reduce the
rate of oxy-haemoglobin dissociation and oxygen availability thereby inhibiting
cell division significantly and thus slowing the formation of new tissue
(Harding, Bale & Assenheimer, 1997). Research has found that a constant
temperature of 37°C promotes both macrophage and mitotic activity during
granulation and epithelialization (Glide, 1992:74; Dealey, 1994:18; Hampton,
1997:6; Miller & Collier, 1997:19; Kloth, Berman, Dumit-Minkel, Sutton,
Papanek & Wurzel, 2000). Extremes of temperature also cause tissue
damage (Flanagan: 1997b:30).
54
3.3.2.3 Wound site
The position of a wound affects its vascularity and determines the mobility of
the wound site. Wounds on or close to joints tend to heal slower as the
constant movement (flexion and extension of the joint) may disrupt the
delicate newly formed tissues (Brychta et al., 1999:41).
3.3.2.4 Local infection
Several researchers suggest that microbial populations greater than 105
colony-forming units per gram of tissue are indicative of infection and
contribute to delayed healing. However, much smaller numbers of certain
bacterial species, for example pyogenic streptococci, may cause infection
(Baxter & Mertz, 1992 and Cooper & Lawrence, 1996b:294). Recent research
debates the relevance of this quantitative measurement as a diagnosis of
infection (Miller & Gilchrist, 1997:7). These authors propose that the diagnosis
of wound infection is not dependent on numbers or state of replication of
bacteria but rather on the response of the individual - the host reaction - to
those bacteria.
Chronic wounds such as pressure sores, are typically seen in the elderly and
the immune response (host reaction) may be absent or diminished. Gilchrist
(1997: 150) points out that there is no evidence that bacteria need to be
removed from chronic wounds for healing to occur. The most obvious sign
though, of wound infection is that it will either not start healing, or that it will
stop healing. This is because wound infection prolongs the inflammatory
phase, causes further tissue damage, delays collagen synthesis and
epithelialization (Flanagan, 1997b:30).
55
3.3.2.5 Foreign bodies, necrotic tissue, slough and eschar
It is well documented that the presence of necrotic tissue, slough and eschar
impair the healing of a wound by impeding epithelial migration and impairing
the supply of nutrients to the wound bed.
It may act as a medium for bacterial growth and subsequent infection (Tilbury,
1991d:25; Glide, 1992:78; Baxter & Mertz, 1992:18; Bennett & Moody,
1995:43; Gilchrist, 1997: 150; Harding, Bale & Assenheimer, 1997; Hampton,
1997:5; Hofman, 1997:53). Additionally foreign bodies, such as cotton wool
fibres, can cause tissue irritation, prolong the inflammatory response and act
as foci for infection (Flanagan, 1997b: 30).
3.3.2.6 Desiccation
Winter (1962:293) compared healing in dry (desiccated) and moist superficial
wounds and found that the moist wounds formed new epidermal covering
40% faster than the dry wounds. The same author concluded that this was
because new epidermal cells could migrate easily across the moist wounds
whereas in the desiccated wounds, the cells had to negotiate the scab, which
took longer. Subsequent research suggests that the inflammatory process is
greatly accelerated in a moist environment, leading to faster healing (Harding,
Bale & Assenheimer, 1997).
Conversely, a dry environment will lead to dehydration and cell death (Tilbury,
1991c:18; Baxter & Mertz, 1992:18; Krasner, 1992:39; Moore, 1996:46 and
Miller & Collier, 1997: 17).
56
3.3.2.7 Pressure, friction and shear
Mechanical forces such as pressure, friction and shear significantly impair
wound healing by prolonging tissue damage (Flanagan, 1997b:30). These
forces are discussed in Sections 2.3.1.1, 2.3.1.2 and 2.3.1.3.
3.3.2.8 Oxygen tension
The role of oxygen in wound healing can appear contradictory. It has been
shown that macrophages, which instigate the healing process, require
hypoxia in order to stimulate angiogenesis (and thereby the formation of new
granulation tissue) and there is evidence that high oxygen concentrations, for
example hyperbaric oxygen therapy, can stimulate wound repair. However, it
has also been shown that hypoperfusion, ischaemia and tissue hypoxia can
inhibit healing (Miller & Collier, 1997:19).
Inadequate oxygen perfusion results in the formation of unstable collagen with
low tensile strength and lower tissue resistance to infection by lessening the
phagocytic activity of leukocytes (Baxter & Mertz, 1992:22; Hampton, 1997:5;
Flanagan, 1997b:30). It can therefore be concluded that the role of oxygen in
wound healing is still being elucidated.
3.3.2.9 Skin maceration
If the peri-wound area is exposed to excess moisture from exudate,
perspiration or incontinence, maceration and damage to the surrounding skin
may occur which may predispose to infection, skin sensitivities, irritation,
further skin breakdown and impede wound healing (Dealey, 1994:72).
57
3.4 CONCLUSION
Optimal wound healing is attained when the systemic and local factors, as
discussed in the preceding paragraphs, are corrected or offset.
58
CHAPTER FOUR
line principles of pressure sore management
59
4.1 INTRODUCTION
The truism, prevention is better than cure, is particularly relevant as far as
pressure sores are concerned. However, despite attempts at prevention,
pressure sores remain a common occurrence. Effective pressure sore
management is best achieved through a team approach involving patients,
their family or caregivers and health care providers. In this chapter the
principles of pressure sore management will be discussed with particular
reference to pressure sore risk assessment; assessment of the patient and
the pressure sore(s); relieving pressure and pressure sore (wound) care
(Laverty, Mallet & Mulholland, 1997:79; Langemo, 1999).
4.2 PRESSURE SORE RISK ASSESSMENT
Pressure sore risk assessment scales attempt to identify the presence of
extrinsic and intrinsic factors that are known to increase an individual's
susceptibility to pressure damage, and to quantify the risk with a numerical
score (Flanagan, 1997a:3; Banks, 1998b:91; Langemo, 1999). Even though
pressure sore risk assessment is part of patient assessment, it should be
used as a guide to pressure sore risk and not as an indicator of pressure sore
development (Banks, 1998b:91). Phillips (1997:44) and Scott (2000:70)
support this view and add that risk assessment tools can only be effective if
used in conjunction with expert clinical judgement.
Norton first researched pressure sore risk assessment in 1962. Numerous risk
assessment tools have since been developed (Birchall, 1993:35; Waterlaw,
1996:54; Healey, 1996:80; Flanagan, 1997a:6; Banks, 1998b:91). The
reported sensitivity and specificity of these tools vary considerably because of
variations in patient groups and/or clinical settings.
60
Specificity is defined as the percentage of patients who do not develop
pressure sores and were predicted not to, and sensitivity is the percentage of
patients who develop pressure sores and were predicted to do so. An ideal
pressure sore risk calculator would have to demonstrate good predictive value
and be both 100% specific and 100% sensitive. However, in reality this is not
possible as sensitivity and specificity have an inverse relationship (Flanagan,
1997b:158; Phillips, 1997:44).
Risk assessment tools have been criticized because little research has been
carried out to test their reliability, and there is concern that some may over-
predict risk, resulting in the ineffective use of scarce resources. However,
Banks (1998b:91) points out that the use of a recognized risk assessment tool
can facilitate clinical decision-making and support requests for pressure
relieving equipment. In the following paragraphs a few of the more widely
known risk assessment scales will be described, indicating the patient group
for whom each one was developed, and the variables used in the scoring
system (see Appendix 7 for examples of each scale discussed in 4.2.1, 4.2.2,
4.2.3,4.2.4 and 4.2.5).
4.2.1 Norton risk assessment scale
The Norton scale was developed in 1962 and is one of the most common and
popular risk calculators because it is quick and easy to use. Variables taken
into account are physical health, mental health, activity, mobility and
incontinence, each giving a numerical score. The lower the score the higher
the risk. Maximum score 20; a score of 14 or below indicates patient at risk
(Torrance, 1983:32; Bassett, 1993:146; Dealey, 1994:91; Walding &Andrews,
1995:33; Banks, 1998b:91; Flanagan, 1998a:484). The Norton scale was,
however, developed in a unit for the care of elderly people and according to
Birchall (1993:35) its application to general nursing must be questioned.
61
4.2.2 Douglas risk assessment scale
The Douglas pressure sore calculator was developed in a male medical ward,
mainly caring for patients following myocardial infarction. It is based on the
Norton scale, and addresses the following variables: nutritional state, activity,
incontinence, pain, skin state, mental state, special risk factors (diabetes,
steroid therapy, cytotoxic therapy and dyspnoea). The lower the score the
higher the risk. A score of less than 18 suggests the patient is at risk of
developing pressure sores (Dealey, 1997:32). Birchall (1993:35) cautions that
although this scale appears to be comprehensive and relatively easy to use,
there is little evidence to support its effectiveness, as the initial research
involved only 28 patients over a one-month period.
4.2.3 Waterlow risk assessment card
This risk assessment card was developed as a more comprehensive guide to
pressure sore prevention and treatment. The risk assessment is more
complex than the Norton scale as it covers many more predisposing factors
that put patients at risk. The Waterlow was developed for use among general
adult populations, the initial research being carried out in a general hospital
caring for medical, surgical, orthopaedic and elderly patients. Variables
include: Build/weight for height, continence, skin type, mobility, sex, age,
appetite, tissue malnutrition, neurological deficit, major surgery/trauma and
medication. The higher the score the higher the risk. Scores are divided into
categories: 10-14 = at risk; 15-19 = high risk; 20+ = very high risk (Waterlow,
1985:49; Healey, 1996:80; Waterlow, 1996:58; Flanagan, 1997b:159; Banks,
1998b:91; Flanagan, 1998a:484; Pang & Wong, 1998:148).
62
4.2.4 The Pressure Sore Prediction scale
The Pressure Sore Prediction Scale (PSPS) was initially developed in 1975
and published in 1987 by Lowthian (Dealey, 1997:32). It was first used in an
orthopaedic setting and has since been implemented in a variety of clinical
areas. The score constitutes the use of a simple six-point questionnaire and
the variables used are: sitting up, unconscious, poor general condition,
incontinence and mobility. The higher the score the higher the risk. Highest
score is 16; scores above six indicate a patient at risk (Dealey, 1997:32-33).
4.2.5 The GosneIl scale
This scale was developed in 1973 by Gosneil in the USA and was based upon
the earlier work of Norton. Nutritional status was added as an assessment
criterion and data concerning admission, discharge, medical diagnosis and
demographic details were also included. Further additions to this scale were
the inclusion of skin appearance, height, weight, vital signs and medications.
The original GosneIl scale was revised in 1987 and again in 1988. The initial
scoring of five risk factors - mental status, continence, mobility, activity and
nutrition were reversed so that the higher the score, the greater the risk of
pressure sore development. The category describing skin appearance was
also expanded to include moisture, temperature, colour and texture. These
changes resulted in a possible risk factor score of between five and 20: the
higher the score, the higher the patient's risk status (Flanagan, 1997b:159;
Flanagan, 1998a:484).
63
4.2.6 The Braden scale
Braden and Bergstrom, who were reviewing nursing practices in nursing
homes, developed the Braden risk assessment score in the USA. The Braden
scale consists of six predisposing factors or variables: sensory perception,
moisture, activity, mobility, nutrition and friction/shear. Included in this scoring
system are specific assessment criteria for each of the risk factors described.
In both categories describing sensory perception and nutritional status, there
is a second range of potential responses, which improves reliability by
reducing user ambiguity.
The nutrition section is specific without being too complicated. Practitioners
are able to identify patients who are receiving tube feeds, parental nutrition or
simple intravenous support.
The sections describing friction/shear and moisture recognize the importance
of these factors in contributing to tissue breakdown and remind the
practitioner of relevant practical considerations.
Most of the identified risk factors are awarded a rating of between one (least
favorable) to four (most favorable) except friction/shear which can be given a
maximum rating of three. The maximum score possible is 23, indicating low
risk status, whilst the minimum score is six, indicating a high-risk patient.
Patients with a score of 16 or less were originally considered to be at risk of
developing pressure sores. However, it has since been recommended that the
cut off point be moved up to 18 (Bergstrom, Demuth & Braden, 1987:417;
Dealey, 1994:91; Dealey, 1997:32; Banks, 1998b: 91; Flanagan, 1998a:484;
Pang & Wong, 1998:148; Langemo, 1999).
64
A recent study carried out by Pang and Wang (1998: 147) in a Hong Kong
rehabilitation hospital compared the predictive power of the Norton, Braden
and Waterlaw scales. Both the Waterlowand Norton scales had relatively
high sensitivity (81% and 95%, respectively), whereas the Braden Scale had
both high sensitivity (91%) and specificity (62%) - highest of the three scales.
All three scales had relatively high negative predictive values (>90%).
However, for the positive predictive value, the Braden Scale scored the
highest percentage of the three scales. Thus, in terms of sensitivity,
specificity, positive predictive value and percentage of correct classification,
the Braden Scale has an advantage over the other two scales. These results
confirm the findings of similar previous studies (Flanagan, 1997a: 6; Hopkins,
Gooch & Danks, 1998:37; Olson, Tkachuk & Hanson, 1998:209).
In the light of the above and the fact that the Braden Scale is used extensively
in various care settings in the USA, this risk assessment tool will be utilized in
this study. Table 4.1 illustrates the Braden Scale.
65
TABLE 4.1: Braden risk assessment scale
Patient's Number: Date of Assessment:
Sensory perception 1. Completely limited: 2. Very limited: 3. Slightly limited: 4. No impairment:
Unresponsive (does not Responds only to painful Responds to verbal Responds to verbal
Ability to respond moan, flinch, or grasp) to stimuli. Cannot commands but cannot commands. Has no
meaningfully to pressure- painful stimuli, due to communicate discomfort always communicate sensory deficit which
related discomfort diminished level of except by moaning or discomfort or need to be would limit ability to feel
consciousness or restlessness, turned, or voice pain or
sedation, OR OR discomfort.
OR Has a sensory Has some sensory
limited ability to feel pain impairment which limits impairment which limits
over most of body the ability to feel pain or ability to feel pain or
surface. discomfort over half of discomfort in one or two
body. extremities.
Moisture 1. Constantly moist: 2. Moist: 3. Occasionally moist: 4. Rarely moist:
Skin is kept moist almost Skin is often but not Skin is occasionally Skin is usually dry; linen
Degree to which skin is constantly by always moist. Linen must moist, requiring an extra requires changing only at
exposed to moisture perspiration, urine, etc. be changed at least once linen change routine intervals.
Dampness is detected a shift. approximately once a
every time patient is day.
moved or turned.
Activity 1. Bedfast: 2. Chairfast: 3. Walks occasionally: 4. Walks frequently:
Confined to bed. Ability to walk severely Walks occasionally Walks outside the room
Degree of physical limited or nonexistent. during day but for very at least once every two
activity Cannot bear own weight short distances, with or hours during waking
and/or must be assisted without assistance. hours.
into chair or wheel chair. Spends majority of each
shift 'in bed or chair.
Table 4.1 contmues ...
66
TABLE 4.1: Braden risk assessment scale continued ...
Patient's Number: Date of Assessment:
Mobility 1. Completely immo- 2. Very limited: 3. Slightly limited: 4. No limitations:
bile: Makes occasional slight Makes frequent though Makes major and
Ability to change and Does not make even changes to body or slight changes in body or frequent changes in
control body position slight changes to body or extremity position but extremity position position without
extremity position without unable to make frequent independently. assistance.
assistance. or significant changes
independent I .
Nutrition 1. Very poor: 2. Probably inadequate: 3. Adequate: 4. Excellent:
Never eats a complete Rarely eats a complete Eats over half of most Eats most of every meal.
Usual food intake pattern meal. Rarely eats more meal and generally eats meals. Eats a total of four Never refuses a meal.
than a third of any food only about half of any servings of protein (meat, Usually eats a total of
offered. Eats two food offered. Protein dairy products) each day. four or more servings of
servings or less of protein intake includes only three Occasionally will refuse meat and dairy products.
(meat or dairy products) servings of meat or dairy supplement if offered, Occasionally eats
per day. Takes fluids products per day. OR between meals. Does not
poorly. Does not take a Occasionally will take a Is on tube feeding or total require supplementation.
liquid dietary supplement, dietary supplement, parenteral nutrition
OR OR regimen, which probably
is nil per mouth and/or Receives less than meets most of nutritional
maintained on clear optimum amount of liquid . needs.
liquids or IV for more than diet or tube feeding.
five days.
Table 4.1 continues ...
67
TABLE 4.1: Braden risk assessment scale Date of Assessment:
Patient's Number:
1. Problem: 2. Potential problem:
3. No apparent
Friction and shear Moves feebly or requires problem:Requires moderate to Moves independently in
maximum assistance in minimum assistance.
During a move skin bed and in chair and hasmoving. Complete lifting probably slides to some sufficient muscle strengthwithout sliding against
sheets is impossible. extent against sheets,
to lift up completely
during move. Maintains
Frequently slides down in chair, restraints, or other
bed or chair, requiring devices. Maintains
good position in bed or
relatively good position in chair at all times.frequent repositioning chair or bed most of the
with maximum
assistance. Spasticity, time but occasionally
contractures, or agitation slides down.
leads to almost constant
friction. Total
A total score of 18 and lower indicates a risk of developing pressure sores score:
(Bergstrom , Demuth & Braden, 1987 :417; Dealey, 1994: 91; Dealey, 1997: 32; Banks, 1998b: 91; Flanag an, 1998a :484; Pang &
Wong, 1998:148)
68
4.3 ASSESSMENT
Assessment is the starting point in preparing to treat or manage a patient with
a pressure sore. Holistic assessment involves the entire person, not just the
pressure sore, and is the basis for planning treatment and evaluating its
effects (Broekkamp, 1994:1; Briggs, 1996:229; Hampton, 1997:5).
Assessment of the pressure sore and the patient will be discussed in the
following paragraphs.
4.3.1 Assessment of the pressure sore
A thorough assessment is the starting point in preparing to treat an individual
with a pressure sore. Assessment forms the basis for planning treatment and
evaluating its effects. It is also essential for communication among caregivers.
Initial assessment of the pressure sore will include the site; stage (including
the absence or presence of sinus tracts, undermining or tunneling);
dimensions (length, width, and depth); appearance of the wound bed
(including colour as well as the presence or absence of necrotic tissue,
slough, granulation tissue, and epithelialization); exudate; odour; the
surrounding skin, clinical signs of wound infection and pain at the wound site.
Pressure sores should be reassessed at least weekly. The Agency for Health
Care Policy and Research (1994:4) proposes that if the condition of the
patient or the wound deteriorates, the treatment plan should be reevaluated
as soon as any evidence of deterioration is noted.
69
4.3.1.1 Site
Pressure sores usually occur over bony prominences, but some areas are
more prone to pressure sores than others. Figure 4.1 (p.71) illustrates
common sites for pressure sores and frequency of ulceration per site. These
findings allow for specific aspects of care that need to be considered such as
adequate pressure relief, reduction of friction and selection of appropriate
dressings. The position of a wound may also be an indication of potential
problems, such as the risk of contamination of wounds in the sacral region, or
immobility caused by wounds on the foot (Dealey, 1994:67).
4.3.1.2 Staging of pressure sores
Classification or staging of pressure sores is just one aspect of assessment.
Its purpose is to clarify and describe objectively the depth and extent of tissue
damage (Dealey, 1994:99; Phillips, 1997:19; Banks, 1998a:23). In practice a
pressure sore grading system has the potential to:
~ Promote the accurate transfer of information between different groups
caring for a patient, allowing assessment of progress and deterioration;
~ Encourage precise documentation and
~ Provide guidance to staff using protocols in decision-making, for example
when making a choice about which pressure-relieving equipment or
dressing to use (Phillips, 1997:21; James, 1998:669).
A grading system can reflect the severity of the sore in a number of ways,
either by measuring the depth of skin affected or, alternatively, by assessing
the stage of tissue breakdown. There are numerous pressure sore staging or
classification systems available. In 1992 a National Consensus Conference
was held in Stirling in the United Kingdom in an attempt to provide a standard
classification system.
70
The outcome of this conference was the publication of the Stirling Pressure
Sore Severity Scale (SPSSS). In arriving at this system the panel considered
12 systems (Waterlow, 1996:54).
Scapula
0.5%
Sacrum
23% --
Ischium
24%
1'-----6%Knee
Pretibial crest
1-----2%
Heel
8% ----
D Prone Supine """"l Sitting ~ Lateralposition position position ~ pressure
Lueckenotte, 1996:791
Figure 4.1: Common sites for pressure sores and frequency per site
71
The same author points out that even though it is impossible to accurately
assess whether any system is better than another, the SPSSS is a consensus
of acknowledged experts in the field. In addition to a standard scoring system
numbering one to four, the Stirling grading system has a third and fourth digit
classification further to describe the wound bed and any infective
complications. James (1998:670) and Waterlow (1996:54) recommend that it
be used for research purposes as it provides a more detailed and
sophisticated wound description (Bennett & Moody, 1995:83; Walding &
Andrews, 1995:34; James, 1998:670). The SPSSS will therefore be utilized as
classification system in this research study. Figure 4.2 illustrates the Stirling
Pressure Sore Severity Scale.
Figure 4.2: The Stirling pressure sore severity scale
Stage 0 No clinical evidence of a pressure sore
0.0 Normal appearance, intact skin
0.1 Healed with scarring .
0.2 Tissue damage but not assessed as a pressure sore
Stage 1 Discolouration of intact skin (light finger pressure applied to site
does not alter the discolouration)
1.1 Non-blanchable erythema with increased local heat
1.2 Blue/purple/black discolouration. The sore is at least Stage 1.
Stage 2 Partial-thickness skin loss or damage involving epidermis and/or
dermis
2.1 Blister
2.2 Abrasion
2.3 Shallow ulcer without undermining of adjacent tissue
2.4 Any of these underlying blue/purple/black discolouration or induration.
The sore is at least Stage 2.
Stage 3 Full-thickness skin loss involving damage or necrosis of
subcutaneous tissue but not extending to underlying bone,
tendon or joint capsule
3.1 Crater withoutundermining of adjacent tissue
3.2 Crater with undermining of adjacent tissue
3.3 Sinus, the full extent of which is uncertain
3.4 Full-thickness skin loss but wound bed covered with necrotic tissue
(hard or leathery black/brown tissue or softer yellow/cream/gray
slough) which masks the true extent if tissue damage. The sore is at
least a Stage 3. Until debrided it is not possible to observe whether
damage extends into muscle or involves damage to bone or
supporting structures.
72
Stage 4 Full-thickness skin loss with extensive destruction of tissue.
Necrosis extending to underlying bone, tendon or joint capsule
4.1 Visible exposure of bone, tendon or capsule
4.2 Sinus assessed as extending to bone, tendon or capsule
Third digit classification - for the nature of the wound bed
X.X.O Not applicable; intact skin
X.X.1 Clean, with partial epithelialization
X.X.2 Clean, with or without granulation but no obvious epithelialization
X.X.3 Soft slough, cream/yellow/green in colour
X.X.4 Hard or leathery black/brown (dead/avascular) tissue
Fourth digit classification - for infective complications
X.X.X.O No inflammation surrounding the wound bed
X.X.X.1 Inflammation surrounding the wound bed
X.X.X.2 Cellulitis bacteriologically confirmed
Waterlow, 1996:56
4.3.1.3 Dimensions
The measurement of a wound has an important place in wound care. Without
baseline and ongoing wound measurements it is impossible to achieve an
objective approach to managing and treating a wound (Dealey, 1994:76;
Hampton, 1997:7), Plassmann (1995:269) adds to this by emphasizing that
the accurate measurement of wound size is vital for assessing the progress of
healing. However, due to the three-dimensional and dynamic structure of
wounds, accurate measurement is difficult. This difficulty stems from three
particular problems, which directly affect the accuracy of any and ali
measurement techniques, Dealey (1994:78), Plassmann (1995:269) and
Banks (1998d:212) describe these problems as the following:
(i) Thedefinition of a wound's margin
The wound margin is usually determined by the subjective assessment of the
human observer who performs the measurements and decides if a particular
part of the area in question belongs to the wound.
73
(ii) Wound flexibility
Wounds that are undermined, large or deep are capable of changing their
appearance significantly, thus jeopardising the reproducibility of
measurements.
(iii) The natural curvature of the human body
Measurement techniques that do not account for the natural curvatures of the
body will also produce inaccurate results.
Despite these problems, various attempts have been made to measure the
area and volume of wounds. In the following paragraphs several area and
volume measuring techniques, as described in the literature, will be reviewed
namely: ruler-based measurements, transparency tracings, photographic
methods, ultrasonic surface scanning, casts, saline, computerized stereo-
photogrammetry, structured light technique, laser triangulation, video image
analysis and magnetic resonance imaging.
4.3.1.3 (a) Ruler-based measurements
This is the simplest measurement technique and is accomplished by
measuring the wound at its greatest length and breadth and the depth if
appropriate. In wounds that are fairly regular in shape this can be a fairly
successful method. In a wound care study to compare healing rates and costs
of two different dressings for pressure sores Sebern (1986:727) calculated the
surface area by assuming an elliptical shape, which provides a more accurate
wound area of a pressure sore. The area is calculated as follows:
Area = TT X r, x r2, where TT = 3.14
74
However, the accuracy may be questionable if many different individuals use
it. Dealey (1994:77) points out that if necrotic tissue or slough is present, the
true wound size will only become apparent as debridement occurs. Wound
measurement will indicate that the wound has increased in size and can give
a misleading picture of wound progress. This technique is inexpensive, readily
available, easily accomplished by most clinicians and causes little patient
discomfort. The technique can become three-dimensional when a depth
measurement is added, for example by gently inserting a sterile swab to the
maximum depth (Langemo, Melland, Hanson, Olson, Hunter & Henly,
1998:337).
4.3.1.3 (b) Transparency tracings
This technique involves tracing the outline of the wound on a flexible two-layer
transparency with an imprinted metric grid. The tracing is made on the upper
sheet, and the lower sheet, which is in contact with the wound, is disposed of
after use (Griffin, Tolley, Tooms, Reyes & Clifft, 1993:64; Dealey, 1994:77).
After the tracing is taken, several methods may be used to determine its area.
One method is to place the transparency on metric graph paper and count the
number of 5 mm2 squares. A less time-consuming method is to cut the
tracings out and weigh them on a precision scale (Bohannon & Pfaller,
1983: 1624). Schubert (1997: 154) describes transparency tracings as an
effective method of measuring wound area as it is inexpensive, rapid, requires
minimal training and provides instant results. This technique may further be
improved by transferring the wound tracings to a computer and having the
measurements taken by hand-held scanners or electronic cameras. The
boundaries of the tracing are automatically identified by the computer
software making this a faster and more accurate technique (Plassmann,
1995:269).
75
4.3.1.3 (c) Photographic methods
The simplest non-contact technique according to Melhuish, Plassmann and
Harding (1994:41), is that of photography and the study of and measurement
of photographs known as photogrammetry. However, in order to monitor the
progress of healing by taking photographs, it is essential to ensure that each
photograph is comparable to the others. To achieve such consistency it is
necessary to exercise as much control as possible over the variables, which
may influence the results (Dealey, 1994:78). Bellamy (1995:313-316) and
Flanagan (1997b:42) suggest that special consideration should be given to
the following:
(i) Choice of equipment
As no two makes of camera are exactly alike, it is recommended that the
same model be used on each occasion. Whether the camera is manual, semi-
automatic or fully automatic is a matter of personal preference, provided that
the photographer has complete control over focusing, magnification and
exposure functions. Additionally a tripod, while not essential, may be useful to
ensure accurate camera positioning and framing of the subject.
(ii) Choice of materials
As the colour of a wound is an important indicator of its condition, only colour
film should be used. Whichever format (prints or slides) is chosen it is
essential to be consistent with the manufacturer, the type and speed of the
film used.
(iii) Choice of processing
Processing and printing should be carried out in the same place on every
occasion to ensure consistent results.
76
(iv) Control of subject
The patient's position in relation to the camera is the most difficult variable to
control. It is therefore advisable to make comprehensive notes on each
occasion and have previous photographs available for reference at
subsequent sessions. If measurements are to be taken from photographs,
then a scale such as a ruler should be placed in the plane of focus and, for
aesthetic reasons, towards the edge of the frame.
(v) Control of lighting
In order to achieve consistent results, the amount, angle and direction of light
falling on the subject must be controlled which will ensure that the subject is
evenly illuminated and that any shadows cast are small. Careful notes should
therefore be made about the angle and direction of light so that repeat
photographs may be taken.
(vi) Control of background
The background of a clinical photograph should be plain and unobtrusive.
Any bright colour will introduce some measure of unwanted colour cast into
the subject. Additionally the background should be even, right to the edge of
the frame.
(vii) Maintaining the same distance
In order to achieve consistent results and to ensure that each photograph is
comparable to the others, the same distance between the camera lens and
the wound surface should be maintained on each occasion.
77
(viii) Consent and storage
Other considerations include obtaining written informed consent from the
patient before taking photographs and ensuring that the images are stored in
a secure place and are not published without prior consent of the patient.
4.3.1.3 (d) Ultrasonic surface scanning
This method has been successfully used but compared with an optical
camera, the resolution is always poor since it is difficult to focus the ultrasonic
waves to a sufficiently narrow beam. According to Plassmann (1995:272)
ultrasonic depth scanners have been useful in the measurement of small
wounds and scars.
4.3.1.3 (e) Casts
Wound volume may be measured with impression materials such as high-
viscosity vinyl poly-siloxane but cheaper and faster measurements may be
obtained by using dental alginate hydrocolloid materials. Usually casts can be
extracted from a lesion without difficulty. However if the shape of a wound
makes it impossible to verify that no material is left in the cavity, this method
should not be used (Dealey, 1994:80; Flanagan, 1997b:41; Plassmann,
1995:272).
4.3.1.3 (f) Saline
Volume measurements may be made by covering the wound with transparent
adhesive film and filling the lesion with sterile saline by injecting it through the
film (Flanagan, 1997b:41).
78
However, experiments have shown that on wound models a precision of more
than 10% is rarely achievable (Plassmann, 1995:272). In some cases it is
impossible to position the patient in a way which allows the wound to be filled
with saline.
4.3.1.3(g) Computerizedstereo-photogrammetry
Stereo-photogrammetry is a system that was developed to obtain a
measurement of the volume of a wound. It accomplishes this by providing a
three-dimensional picture from two photographs taken simultaneously from
different angles. The image thus obtained is measured and analyzed by
computer. Although this has been found to be suitable for clinical trials, it is a
costly procedure requiring trained personnel (Dealey, 1994:79).
4.3.1.3(h) Structured light technique
Using this technique the wound area is illuminated by a projector with a set of
parallel strips of light. A camera is connected to an image-processing
computer and from the known positions of the camera and projector the
observed intersection points of the strips of light with the wound's surface, a
three-dimensional representation of the observed area can be produced by
triangulation (Dealey, 1994:79; Plassmann, 1995:272; Flanagan, 1997b:41).
This technique has formed the basis of the development of the MAVIS project
(Measurement of Area and Volume Instrument) initiated by Jones &
Plassmann (1996) and continued by an interdisciplinary team in the medical
laboratories at the University of Glamorgan. The aims of the MAVIS project
are to measure wound dimensions without physical contact to achieve a
precision of about 5%, to make a portable and easy-to-use instrument and to
make measurements rapidly (Berris & Sangwine, 1997).
79
4.3.1.3 (i) Laser triangulation
A new technique that uses light from lasers in the same way as ultrasound is
currently used is under investigation. By scanning the wound with low
powered lasers it is possible to obtain a three dimensional image. However,
the special equipment requires both specialized rooms and precise settings
which restricts its use (Melhuish, Plassmann & Harding, 1994:41).
4.3.1.3. U) Video image analysis
Video image analysis of wounds using video cameras and image processing
software is becoming very popular and can be used to look at many different
parameters of a wound such as size, shape and colour. One such system is
the Verge Videometer Measurement and Documentation (VeVMD). Using this
system the wound can be seen on a computer screen with a target plate to
help coordinate consistent measurement of the wound, regardless of distance
from the camera, angle or position of the patient (Melhuish, Plassmann &
Harding, 1994:41; Beaumont & Anderson-Dam, 1998:20; Salcido, 2000).
However, the cost of these systems is still prohibitively expensive.
4.3.1.3 (k) Magnetic resonance imaging
Magnetic resonance imaging of wounds allows a detailed analysis of wound
size, shape and dimensions; however, the equipment is very expensive and
must have a purpose-built environment for use (Melhuish, Plassmann &
Harding, 1994:41).
80
Finally, most authors agree that regardless of the technique used, what is of
the greatest importance is consistency in the use of the measurement
technique to determine actual changes (Dealey, 1994:78; Bellamy, 1995:316;
Flanagan, 1997b:42; Langemo et a/., 1998:339; Beaumont & Anderson-Dam,
1998:16).
In this study four wound measurement techniques, namely ruler-based
measurements, transparency tracings, saline volume measurements (where
possible) and standardized digital wound photography were be utilized. The
results of each method were triangulated to achieve a final measurement.
Additionally the researcher performed each of these techniques personally
thereby increasing the reliability and validity of the measurements.
The measurement of a wound has an important place in wound care. Without
baseline and ongoing wound measurements it is impossible to achieve an
objective approach to managing and treating a wound (Dealey, 1994:67;
Hampton, 1997:7). Plassmann (1995:269) emphasizes that the accurate
measurement of wound size is vital for assessing the progress of healing.
4.3.1.4 Appearance of the wound bed
The appearance of the wound bed provides an indication of the phase it has
reached on the continuum of healing, as well as any complication that may be
present (Krasner, 1992:37; Dealey, 1994:67; Krasner, 1995:44).
A black wound indicates a necrotic wound, often with hard eschar present.
This dehydrated and dead tissue will delay healing and requires removal to
provide a healing environment. Krasner (1995:45) describes two types of
yellow wounds, namely those that are infected and those that contain fibrous
slough. Infected wounds are characterized by yellow, light green or cream-
coloured exudate (pus), comprised of bacteria, cellular debris, and leukocytes
(Hampton, 1997:7).
81
Fibrous slough is usually yellow, cream-coloured, or white. It often appears
soft and stringy and may stick to the wound bed. As slough provides an
excellent medium for bacterial proliferation, it needs to be removed to
optimize the healing process.
A red wound indicates the presence of granulation tissue. Healthy granulation
tissue may appear deep pink or red in colour and is moist with raised
"granules". These are delicate loops of capillaries, which are easily damaged.
A granulating wound represents a healthy, healing wound and the
maintenance of an optimum healing environment is therefore essential
(Dealey, 1994:70; Krasner, 1995:44; Hampton, 1997:7; Flanagan, 1998b:508-
510). An overabundance of granulation tissue or hypergranulation will inhibit
the migration of epithelial cells and thus delay the healing process.
It appears that the cause of hypergranulation is an excessive inflammatory
response that results in an increase in growth factors and stimulation of
ground substance formation and fibroblast proliferation. However, the reason
this occurs is unclear (Dunford, 1999:506).
Treatment methods used in the community for hypergranulation include the
following:
~ change from an occlusive to a vapour permeable dressing such as a
polyurethane dressing;
~ application of light pressure to the wound bed by the addition of
supplementary padding;
~ short-term application of a low dose of corticosteroids;
~ removal using a caustic substance such as silver nitrate;.
~ allowing the hypergranulation to resolve itself without treatment
According to Dunford (1999:507) there is no consensus as to the correct
treatment for this condition.
82
A pink wound represents an epithelialising wound. Epithelial tissue migrates
from the wound margins and from undamaged hair follicles and moves over
the wound surface once granulation is level with the surrounding skin
(Harding, Bale & Assenheimer, 1997; Hampton, 1997:7; Banks, 1998d:211).
Another method that can be used to assess and document the appearance of
the wound bed is to place a metric grid (as discussed in section 4.3.1.3 [bl)
over a photographic image of the wound. The black, yellow, red and pink
areas are then demarked and the number of squares in each area counted
and expressed as a percentage of the total area (total number of squares) of
the wound surface (Andriessen, 2000). In the absence of advanced
technology this method, even though tedious and time consuming, does
provide a more accurate and objective assessment of the wound appearance.
Therefore this method will be used to assess the appearance of the wound
bed in this study.
4.3.1.5 Exudate
The amount of wound exudate varies during the different phases of the
healing process. In general, exudate production decreases as the wound
progresses towards healing (Dealey, 1994:67; Thomas, 1997a:327). Although
chronic wounds such as pressure sores are associated with the presence of
some exudate, normal granulation tissue is relatively dry. Therefore, the
sudden appearance of increased amounts of exudate in a wound may be an
indicator of an infection. According to Miller and Gilchrist (1997:10) this is due
to the underlying capillaries dilating as part of the inflammatory response, in
order to allow leukocytes in particular to migrate to the source of an infection.
The increased permeability of the capillaries also allows for the leakage of
greater quantities of plasma. In addition to assessing the amount of exudate,
the appearance of the exudate needs to be determined. Exudate may appear
bloody, serous, serosanguinous or purulent and may be clear, pink, light red,
dark red, pinky yellow or green in colour (Bennett & Moody, 1995:44).
83
However, in a healthy healing wound the exudate normally appears pale
yellow in colour (Thomas, 1997a:327). Terms used to describe exudate
volume include heavy, moderate and light but these are imprecise, subjective
assessments.
Colour, consistency, purulence and odour of exudate are other characteristics
widely used to define wound status for which there are no objective
measurements (Nelson, 1997:11). Attempts to provide more objective
descriptions of exudate volume include weighing of dressings, measuring the
diameter of drainage area on the dressing and, in the case of gauze
dressings, the number of dressings through which exudate strike-through
occurred. However, none of these attempts have been proven to be very
successful and/or practical especially in community settings. Therefore, for
the purposes of this study, the researcher described exudate level as: high,
medium or low and indicated amount of exudate change as: unknown (on
initial assessment), same as last assessment, increasing or decreasing. Even
though these are subjective descriptions, the reliability of this assessment
method was improved by the fact that the researcher performed all the
dressing changes personally and was able to compare each assessment with
the preceding one.
4.3.1.6 Odour
All wounds have some smell associated with them. However, Miller and
Gilchrist (1997:12) point out that the presence of an offensive odour may
indicate the possibility of infection. The smell from malodourous wounds is
caused by a cocktail of volatile agents that includes short chain organic acids,
(n-butyric, n-valeric, n-caproic, n-haptanoic and n-caprylic) produced by
anaerobic bacteria, together with a mixture of amines and diamines such as
cadavarine and putrescine that are produced by the metabolic processes of
other proteolytic bacteria (Thomas, Fisher, Fram & Waring, 1998).
84
Infection caused by anaerobic bacteria such as Bacteriodes or, less
commonly, Clostridium welchii, often produce an acrid or putrid smell due to
the presence of necrotic tissue. Aerobes such as Klebsiella, Proteus and
Pseudomonas tend to produce strong "fishy" odours (Bennett & Moody,
1995:63; Thomas et al., 1998).
4.3.1.7 Surrounding skin
From the literature it is evident that little attention has been given to the need
to care for the skin around the wound. The skin surrounding the wound may
be intact, erythematous, indurated, edemataus, fragile, dry-scaling or
macerated. Intact, healthy skin is vulnerable to maceration, erosion and
insults from wound exudate, repeated dressing changes or other trauma and
therefore needs to be protected (Krasner, 1992:40). Nelson (1997:11) adds
that wound exudate may exacerbate peri-wound skin damage either directly
or by inducing excoriation and delay healing by provoking a local irritant or
allergenic contact dermatitis.
4.3.1.8 Pain at the wound site
The impact of pain on the patient has been well documented in the literature
and a discussion thereof falls beyond the scope of this review (Bennett &
Moody, 1995:41). It is imperative however, that all patients should be
assessed for pain related to the pressure sore or its treatment. Lindholm
(1998:1) stresses the importance of pain assessment and that caregivers
should not assume that because the patient is unable to express or respond
to pain, that it does not exist.
85
Research has shown that a patient's own report is the single best indicator of
pain and an appropriate pain assessment instrument is therefore required
(Pasero, 1997:19). Many patients are unable to understand or relate to the
often-used zero-to-10 numerical pain rating scale. The same author reports
that the Wong-Baker Faces Pain Rating Scale, as seen in Figure 4.3, has
been found to be easier to use and friendlier.
@@@@®®
o I 2 ~ 4 5
Pasero. 1997:19
Figure 4.3: Wong-Baker faces pain rating scale
Several studies done by Wong (1993), Stein (1995) and Keck (1996), as cited
by Pasero (1997:19), have confirmed the validity and reliability of the Faces
scale and it was therefore used in this research study.
4.3.1.9 Clinical signs and symptoms of wound infection
The very nature of wounds, a discontinuity of the epidermis resulting in the
presence of serous exudate, makes them prone to acquiring and frequently
becoming colonized with a variety of bacteria. However, it is important for the
clinician to distinguish between contamination, which is the presence of non-
multiplying bacteria and colonization, which is the presence and multiplication
of bacteria with no host reaction. Infection occurs when colonizing
microorganisms in tissue result in the appearance of distinctive signs also
referred to as an associated host reaction (Cooper & Lawrence, 1996a:235;
Miller & Gilchrist, 1997:8). The response of individual patients to the presence
of bacteria within their wounds varies from person to person. The term host
reaction describes the variety of different signs and symptoms that may occur
once bacteria overwhelm the body's normal healing process.
86
Wound infection may therefore be indicated if one or more of the following are
present:
<$> Inflammation and increased temperature around the wound.
<$> Redness (erythema).
<$> Swelling (oedema) or cellulitis.
<$> New or increased pain in or around the wound.
<$> An increase or change in wound exudate.
<$> Granulation tissue which is friable and bleeds easily.
<$> Granulation tissue of an unusual darker colour.
<$> Odour which has changed or become unpleasant.
<$> Unusual staining on the wound dressing when removed.
<$> General malaise in the patient.
<$> A non-healing wound or a wound that is not healing at the expected
rate.
<$> Tissue, sometimes at the base of the wound, which does not progress
to healing.
<$> Wound breakdown or dehiscence.
<$> Presence of pus (purulent discharge).
<$> Superficial bridging / pocketing at the base of the wound.
<$> Fever.
<$> Lymphangitis (AHCPR, 1994: 19; Cutting & Harding, 1994: 198; Dealey,
1994:68-69; Mackenzie & Ziady, 1995:27; Harding, 1996b:391;
Gilchrist, 1996:386; Hollingworth, 1997:8-9; Miller & Gilchrist, 1997:9;
Andriessen, 1999a:2).
Flanagan (1997b:35) emphasizes that any factors causing immuno-
suppression will influence a patient's ability to respond classically to the
presence of infective organisms.
87
Immuno-suppressed patients may present with generalized septicaemia
without any localized evidence of wound infection as described above. The
same author cautions that failure to discriminate between the normal
inflammatory response and the presence of infection may further complicate
accurate assessment of clinical wound infection. For the purposes of this
study the researcher assessed patients for any of the above signs and
symptoms whilst considering risk factors, listed in Table 4.2, which may
predispose patients to infection.
TABLE 4.2: Risk factors which may predispose to wound
infections
Risk Factors Rationale
Age Patients over 65 years have a significantly higherincidence of wound infection.
Build/height for weight Obesity increases wound infection rate to 13.5%.
Nutritional status Poor nutrition increases the infection risk.
Hyperglycaemia affects the body's defence
Diabetes mechanism by impairing the response of white blood
cells - neutraphils in particular.
Special risks Irradiation, steroids and immunosuppressive drugscause greatly increased infection rates.
Some underlying diseases may directly affect the
healing process, whilst others may cause a level of
Underlying disease disability which may affect the patient's ability to
maintain safe standards of hygiene, thus increasing
the risk of infection.
(Dealey, 1994:29,30 and Silhi, 1998:51)
88
4.3.2 Assessment of the patient
Assessment of the patient should address the physical health and
complications, nutritional assessment and management and the psychosocial
assessment and management.
4.3.2.1 Physical health and complications
Since a pressure sore should be assessed in the context of the patient's
overall physical and psychosocial health, a complete history and physical
examination should be performed. Additionally, wound care practitioners
should be alert to complications associated with pressure sores. These
include amyloidosis, endocarditis, osteomyelitis, bacteraemia, advancing
cellulitis, heterotopic bone formation, maggot infestation, meningitis, perineal-
urethral fistula, pseudo-aneurysm, septic arthritis, sinus tract or abscess,
squamous cell carcinoma in the pressure sore and systemic complications of
topical treatment such as iodine toxicity and hearing loss after topical
neomycin and systemic gentamyein (AHCPR. 1994:4).
4.3.2.2 Nutritional assessment and management
Numerous studies have linked malnutrition with pressure sores (Bridel,
1993:236; Dealey, 1994:86; Lewis, 1996:483; James,1997a:8; Lewis,
1997:41; Banks, 1998f:318).
Nutritional screening is therefore an essential part of the initial assessment.
The goal of nutritional assessment and management is to ensure that the diet
of the patient contains nutrients adequate to support healing. In this study the
patients' nutritional status was assessed by means of the Braden risk
assessment scale.
89
4.3.2.3 Psychosocial assessment and management
The presence of a wound, especially a chronic wound, may cause stress,
anxiety and depression in a patient. In some cases anxiety may even evoke
dermatological conditions (Dealey, 1994:32). Therefore, a psychosocial
assessment that provides the information necessary to formulate a plan of
care consistent with individual and family preferences, goals and abilities, is
necessary. According to the Agency for Health Care Policy and Research
(1994:7) the goal of psychosocial management is to create an environment
conducive to patient adherence to the pressure sore treatment plan.
Thus far two of the four basic principles of pressure sore management have
been discussed, namely: pressure sore risk assessment and assessment of
the pressure sore(s) as well as the patient. In the following sections relieving
pressure and pressure sore (wound) care will be reviewed.
4.4 REUEVING PRESSURE
The most important prevention practice that must be achieved on a consistent
basis is minimization of pressure over bony prominences and existing
pressure sores (patterson & Bennett, 1995:920). In the following paragraphs
positioning techniques and support surfaces for both bed- and chair-bound
patients will be discussed.
90
4.4.1 Bed-bound patients
Positioning devices may be used to raise a pressure sore off the support
surface. Where the patient is no longer at risk for developing pressure sores,
these devices may reduce the need for pressure-reducing overlays,
mattresses and beds. According to the AHCPR (1994:9) a written
repositioning schedule should be established based on the patient's risk for
additional sores and on the response of the tissue to pressure. The same
authors propose that patients at higher risk of additional sores and those with
a longer duration of reactive hyperaemia should be turned more frequently.
Bed-bound patients judged unable to reposition themselves should be turned
gently and without causing additional mechanical trauma, sequentially from
back to left to right side every two to three hours. However, care should be
taken to avoid placing direct pressure on the greater trochanter and lateral
malleolus by using the so-called 30° tilt technique. This technique involves
placing the patient in a laterally inclined position, supported by pillows, with
their back making a 300 angle with the support surface. Positioning devices
such as pillows should be placed between the knees and lower legs to relieve
pressure, as well as along the back and arms to maintain optimal positioning
(Dealey, 1994:93; Patterson & Bennett, 1995:920).
When supine, heels must be elevated off the support surface to prevent
pressure sores from developing. This, according to Patterson and Bennett
(1995:920), is a common and potentially devastating complication in patients
recovering from hip fractures and strokes. In addition the head of the bed
should be maintained at the lowest degree of elevation consistent with
medical conditions and other restrictions. Maklebust and Sieggreen (1996)
recommend that the head of the bed should not be raised more than 30
degrees. They also suggest that patients who must have the head of the bed
elevated during meals or tube feedings should have the head lowered again
about one hour after eating.
91
The most commonly used devices thought to relieve pressure and prevent
pressure sore formation, include sheepskin fleeces and foam or air rings
(doughnut-shaped devices). Sheepskin fleeces can absorb moisture thereby
reducing the risk of friction. However they do not reduce pressure.
Sheepskins can also increase the risk of infection and should therefore be
laundered frequently. However, this causes them to become matted and they
may form ridges under the patient, causing localised pressure damage. Foam
or air rings do not prevent pressure sores either. In fact they increase
pressure around the ring, causing congestion in the centre. This may result in
oedema and blister formation (Banks, 1998c:159). The tissue in the ring can
also become ischaemic from lack of blood flow as a result of the pressure.
Consequently sheepskins and rings are not considered to be pressure
relieving equipment (AHCPR, 1994:12-13; Patterson & Bennett, 1995:921).
The use of proven pressure relieving equipment is a useful adjunct to the
main preventive measure of regular positioning. The different types of
pressure relieving equipment include the following:
~ Overlays
~ Mattresses
~ Beds
~ Chairs
~ Cushions
~ Padding
~ Pillows
92
The literature refers to various terms when discussing pressure relieving
equipment. Therefore the following terms will be defined.
o Interface pressure
The pressure at the interface between the surface on which an individual is
sitting or lying and a bony prominence. It is usually described in terms of the
pressure exerted by the surface upon the individual.
o Support system
A general term used to describe all pressure relieving equipment.
Pressure relieving equipment
Equipment that moulds or contours itself around the body. This reduces the
pressure over the bony prominenees by distributing the pressure.
DOverlays
These are also called toppers and are laid on top of a mattress.
Mattresses
These are intended to replace the ordinary mattress. If they are laid on top of
an ordinary mattress, they may be too high and unstable for safe patient care.
o Beds
Total systems comprising a bedframe and mattress
93
Cl Dynamic systems
Support systems that actively provide pressure relief or pressure reduction.
Cl Static systems
Support systems that remain stable.
Young (cited in Dealey, 1997: 58) proposed a number of criteria by which
support systems may be assessed or selected for use. Young's criteria are as
follows: effectiveness, ease of use, maintenance, ease of nursing procedures
and patient acceptability.
Using these criteria Table 4.3 summarises information about the different
types of overlays, mattresses and beds.
TABLE 4.3: Assessing overlays, mattresses and beds
Ease of
Effectiveness Ease of use Maintenance nursing Patient
procedures acceptabil ity
Good pressure Generally
reduction - for good - raises
low to medium height of bed -
risk patients consideration
with transfers
Only May find it cold
demonstrated move to touch
for operating
table use
Table 4.3 continues ...
94
TABLE 4.3: Assessing overlays, mattresses and beds continued ...
Ease of
Effectiveness Ease of use Maintenance nursing Patient
procedures acceptabil ity
Generally
good
Some training
needed, but
fairly simple
to use
Some training
needed, but
fairly simple
to use
Performs
better than a required for grounding
standard
mattress - for
medium risk
nts
Suitable for Some training Mostly good;
high risk needed; fairly maintenance some find it a
patients and simple to use check little hard
those with
pressure
sores
Table 4.3 continues ...
95
TABLE 4.3: Assessing overlays, mattresses and beds continued ...
Ease of
Effectiveness Ease of use Maintenance nursing Patient
procedures acceptability
k:~,~ '-.' ~, ';';H:'_"".1.I'IIr. :..-: 'I'Ii '1t': '''11, tn u», '*-~ '*-"'1 ,,' -~, ';~':;~
Suitable for Some training Annual Generally no Mostly good;
high risk needed; fairly maintenance problems some find
patients and simple to use check movement
those with unpleasant
pressure
sores
1"'+' y -: .,',; ;Q,w./~~""}."f.::::IifjIF."'.u, ~..._"(. 'iJ~"i ''-;.'' Cl,.•L,
Suitable for Some training Equipment Generally no Some find the
high risk needed; fairly most often problems pump noisy
patients simple to use rented
~V1' t' '.'" r.o.'.1~i..(. 'w,,~, ,-=..... ,.,', ·:.t··~..", . L;;;'__~ tr'''-\:'':to;,. T}',J ':"'~~';~~ ;J~~
Suitable for Complex Usually rented Generally no Generally
high risk equipment problems - good
patients and training some may find
those with needed the bed high
pressure
sores
li~.-r.: i~'~ ,,\~.1' ~. :-:." T;,...·!ffï!51mr.~ "~.• ,~ li .~~~1;',: -. <.' ..-
Suitable for Training Usually rented Generally no Generally
high risk needed problems good
patients and
those with
pressure
sores
(Banks, 1998c:159-160; Pnng, 1998:173-174; Groen & Groenier. 1999:335;
Scott, Baker, Kelly, Stoddard & Leaper, 1999:437-439; Russel, Reynolds,
Carr, Evans, & Holmes, 2000:52-55; Gaymar Industries Inc., 2000)
As can be seen in Table 4.3 a variety of support surfaces have been shown to
provide an environment in which pressure sores improve. According to the
AHCPR (1994:11) however there is no compelling evidence that one support
surface consistently performs better than all others, under all circumstances.
Therefore, the caregiver should consider several factors when selecting a
support surface including the clinical condition of the patient, the nature of the
care setting and the characteristics of the support surface. Another obvious
and important factor to consider is the cost.
96
Many of the pressure support systems discussed in Table 4.3 are costly and
beyond the reach of the majority of patients in community settings. It is
therefore imperative that caregivers in community settings emphasize the
importance of frequent repositioning, the 30° tilt technique and the correct use
of pillows. It should also be noted however, that support surfaces are only one
part of a comprehensive treatment plan. Should a pressure sore fail to heal,
the entire plan should be re-evaluated before the support surface is changed.
4.4.2 Chair-bound patients
According to Collins and Shipperley (1999: 123) seated individuals are at risk
from developing pressure damage for the following reasons:
~ A small body surface area has to support a disproportional amount of
body weight;
~ The anatomy of the pelvis makes it difficult to maintain stability, leading
to individuals adopting a poor position;
~ The properties of the seating cushion may be inadequate for the
patient or;
~ The chair itself may be of a poor design or in poor condition.
A patient who has a pressure sore on a sitting surface should avoid sitting.
However, if the pressure on the sore can be relieved, limited sitting may be
allowed. Proper positioning is important whilst sitting and the caregiver should
consider postural alignment, distribution of weight, balance, stability and
pressure relief when positioning sitting individuals. For immobile patients in
chairs, repositioning should occur every hour given the greater pressure at the
sacrum with sitting. Individuals who are able should be taught to shift their
weight every 15 minutes while seated (Dealey, 1994:97; AHCPR, 1994:12;
Patterson & Bennett, 1995:921; Dealey, 1997:70).
97
Many chairs have a reclining back of between 150 and 400 which puts the
patient in a semi reclining posture. This may make it more difficult for the
patient to get up. Dealey (1994:97) recommends that a chair should have a
recline of not more than 100 enabling the patient to move more freely.
Cushions may be added to chairs to improve pressure relief, but the same
author states that the cushion should not make the chair so high that the
patient's feet do not touch the floor.
Wheelchairs have a canvas base which exerts pressures up to 226 mmHg
(Rithalia cited in Dealey, 1994:97). It is therefore essential that a cushion
should always be used in a wheelchair. A wide range of cushions is available
and wheelchair-bound patients need to have a specialist assessment to
identify the cushion most suited to the specific needs of each one.
Since pressure is considered to be the most important causative factor in the
aetiology of pressure sores, the pressure relieving principle of pressure sore
management is vital. In the following section the final principle in pressure
sore management namely pressure sore (wound) care, will be discussed.
4.5 PRESSURE SORE (WOUND) CARE
Initial care of the pressure sore involves protection of the surrounding skin,
wound cleansing, debridement, the application of appropriate dressings and
possibly adjunctive therapy.
4.5.1 Protection of the surrounding skin
The surrounding or peri-wound skin is vulnerable and needs to be both
cleansed and protected (Krasner, 1992:40).
98
Hence the following measures may be implemented:
~ Thoroughly, but gently without causing undue trauma, cleanse the
surrounding skin with a mild non-irritating, hypo-allergenic soap and
water and dry well.
~ Apply a skin sealer such as Skin-prep® or affix transparent film to the
surrounding skin.
~ Use an appropriate absorbent dressing on wounds with a high level of
exudate.
~ Apply a hydrocolloid frame to the surrounding skin to which adhesive
tape can be affixed.
~ Clothing or tube gauze instead of adhesive tape may be used to keep
dressings in place.
~ A porous adhesive tape such as Micropore® may be used.
~ Rotate skin areas to which adhesive tape is applied.
~ Adhesive tape corsets and safety pins may be used to hold dressings
in place thereby obviating the need to renew the tape at every dressing
change (Krasner, 1992:40; Bradley & Pupiales, 1997:43 and Brychta et
al.,1999:110).
Dealey (1994:72) proposes that further research into this aspect of wound
care is much needed.
4.5.2 Wound cleansing
Wound healing is optimized and potential for infection significantly decreased
when all necrotic tissue, excess exudate, metabolic wastes, foreign debris or
wound surface contaminants are removed from the surrounding skin and
wound surface (Frantz & Gardner, 1994:38; Miller & Gilchrist, 1997:15-16).
99
According to Glide (1992:76) wound exudate appears to play an active role in
wound cleansing and exudate should therefore be left undisturbed unless it is
profuse and causing discomfort or hygiene problems to the patient or if it is
obviously infected. The same author cautions that repeated cleaning of a
wound that is clean, with very little exudate and signs of healthy granulation,
may in fact do more harm than good. Unnecessary, excessive or
inappropriate cleaning can traumatize newly formed, delicate tissues, reduce
the surface temperature of the wound and remove exudate which itself may
possess bactericidal properties, growth factors and proteases, thus delaying
the wound healing process (Leaper, 1998:373). The Agency for Health Care
Policy and Research (1994: 15) supports this view and proposes that the
benefits of obtaining a clean wound must be weighed against the potential
trauma to the wound bed as a result of cleaning. Considering the above,
wound cleansing may be defined as the removal of both organic and inorganic
debris from the wound bed and surrounding skin, whilst maintaining the
optimum local environment to facilitate wound healing.
4.5.2.1 Wound cleansers
Over the years many different cleansing solutions (medicated and non-
medicated) have been in vogue for wound cleaning. The use of antiseptics
has been one of the most controversial issues in wound care over the past
decade.
Research has found that antiseptics have limited advantage over normal
saline and some antiseptics can adversely affect blood flow in the healing
wound. Therefore the gains made in killing bacteria are more than
counterbalanced by the losses in interfering with the wound healing process
(Glide, 1992:76). For the purposes of this study wound cleansers are defined
as any agent used for cleansing a wound. A brief overview of some cleansing
agents that have traditionally been used, is provided in the following
paragraphs.
100
4.5.2.1(a) Cetrimide
Cetrimide is effective against a wide range of Gram-positive and Gram-
negative organisms. It is often used in combination with chlorhexidine -
particularly in the initial cleansing of dirty wounds. An example of such a
combination is Savlon®, which is a combination of 15% cetrimide and 1,5%
chlorhexidine gluconate. Cetrimide however, has a toxic effect on fibroblast
cells in culture and may cause irritation and sensitization. It is therefore not
recommended as a routine cleanser of non-infected wounds (Frantz, 1991:48;
Tilbury, 1991b:20; Dealey, 1994:12; Murphy, 1995:78; Bennett & Moody,
1995:65; Flanagan, 1997b:60).
4.5.2.1(b) Chlorhexidine
Chlorhexidine 0,5% solutions are widely used and are effective against a wide
range of Gram-positive and Gram-negative organisms and some fungi, but
ineffective against acid-fast bacilli, spores and viruses. Examples of
chlorhexidine solutions are Hibitane®, Hibidil® and Hibisol®. The efficacy of
chlorhexidine is rapidly reduced by organic matter such as blood, pus and
soap. Acquired resistance has been reported with Proteus mirabilis and
Pseudomonas aeruginosa (Murray, 1988:75; Tilbury, 1991b:20; Dealey,
1994:12-13; Murphy, 1995:78; Lawrence, 1996:45).
4.5.2.1(c) Chlorinated solutions
These include EUSOL (Edinburgh University Solution of Lime), Dakin's
solution (surgical soda solution), Chloramine-T and Milton®. From a review of
the literature several objections to the use of hypochlorites have been
identified and include the following:
~ Rapid deactivation in the presence of organic matter.
~ Cytotoxic - particularly to fibroblasts, keratinocytes and leukocytes.
101
~ Prolong the inflammatory response.
~ Reduce capillary flow.
~ May cause acute renal failure and hyponatraemia.
~ Damage granulation and epithelial tissue.
~ Reduce collagen synthesis and decrease wound tensile strength.
~ Can act as an irritant to both the wound and the surrounding skin and
cause oedema.
~ Can cause some patients pain on contact.
~ Have a short shelf life.
~ Usage is both costly and time consuming as it requires frequent
dressing changes (Tilbury, 1991b:17; AHCPR, 1994:15; Dealey,
1994:14; Frantz & Gardner, 1994:38; Patterson & Bennett, 1995:923;
Whittington, 1995:33; Cooper & Lawrence, 1996c:379; Lawrence,
1996:44; Flanagan, 1997b:59-60; Miller & Gilchrist, 1997:13).
In view of this evidence several authors question the justification for their
continued use and according to Murphy (1995:78) the British National
Formulary no longer recommends them. There is however, still a body of
medical opinion that questions this evidence and prescribes and supports the
use of hypochlorites.
Critique against this evidence is the following:
~ There appears to be a lack of consensual findings reported in the
literature regarding the effects of hypochlorites on wound healing.
~ Much of the research has methodological weakness.
~ Some studies are anecdotal and descriptive.
102
~ Studies reporting life threatening side-effects document single cases
only.
~ As many studies make use of animal wound models, the relevance of
these findings remains uncertain and questionable.
~ Very few studies have been conducted using humans.
~ Nursing literature has had the tendency to refer to these studies
without adopting a critical stance (Flanagan, 1997b:60).
It could be concluded that with the development and availability of alternative
wound cleansers that are safe, effective and easy to use, the continued use of
hypochlorites is risky.
4.5.2.1 (d) Hydrogen peroxide
Hydrogen peroxide has an oxidizing effect, which destroys bacteria. It reacts
with catalase in wounds to cause frothing thereby helping to lift out foreign
matter. Its effect lasts for the short period over which oxygen is released. It is
also deactivated by the presence of organic matter. Hydrogen peroxide is
cytotoxic to fibroblasts unless diluted to a strength of 0,003%.
However, this dilution is ineffective against bacteria (Dealey, 1994: 13).
Irrigation with hydrogen peroxide under pressure or into cavities may cause
oxygen embolus and surgical emphysema. It may also cause an irritant skin
response (Murray, 1988:75; Tilbury, 1991 b:20; Frantz & Gardner, 1994:38;
Bennett & Moody, 1995:65; Maklebust, 1995:48; Patterson & Bennett,
1995:65; Whittington, 1995:33).
4.5.2.1 (e) Iodine
Iodine is a broad spectrum antiseptic available in both an alcohol and an
aqueous solution. The latter is used in wound care, usually as povidine iodine
10% which contains 1% available iodine. It is used as a skin disinfectant and
to clean grossly infected wounds.
103
Studies have found it to be effective against MRSA (Methicillin Resistant
Staphylococcus aureus). Lawrence (1998b:422) cautions that the findings of
these studies may be attributable to methodological bias. According to Dealey
(1994: 13) research has found it to be cytotoxic to fibroblasts unless diluted to
0,001%, that it retards epithelialization and lowers the tensile strength of the
wound. It has also been reported that povidine 5% damaged the micro-
circulation of the healing wound, but that a 1% solution was innocuous
(Ferguson, 1988:55; Tilbury, 1991b:21; Lawrence, 1996:44).
Its antimicrobial action is reduced by contact with organic matter such as pus
and exudate, therefore the preparations must be applied at intervals
sufficiently short for the brown colouration to persist (active iodine is brown,
inactivated iodine converts to colourless iodides). Toxic effects that can be
associated with iodine include mental depression, nervousness, insomnia,
myxoedema, hypersensitivity and skin reactions (Lawrence, 1998b:422). The
same author adds that the likelihood of encountering these adverse effects
depends on the concentration and the particular use of povidone-iodine.
Due to reports of its adverse effects, as described above, some authors have
questioned its use in open wounds. However, new, low-concentration, slow-
release formulations that have been developed appear to be safe, have useful
antimicrobial properties and may be effective for the treatment of a variety of
wounds. In view of these new developments the European Tissue Repair
Society unanimously agreed in 1997 that the use of iodine in wound care
should be reconsidered (Gilchrist, 1997:150).
4.5.2.1 (f) Phenol solutions
Clear soluble phenol solutions include White phenol, Lysol® and Dettol®.
These solutions are active against staphylococci, mycobacteria and Gram-
negative bacteria such as pseudomonas.
104
As they are easily deactivated by organic matter and soap, they are used to
disinfect clean environmental surfaces. Although effective as an
environmental disinfectant, their use as routine wound cleansers is
inappropriate (Ziady, Small & Louis. 1997:111).
4.5.2.1(g) Ringer's lactate
Irrigation with Ringer's solution contributes to efficient wound cleansing
(Brychta et a/., 1999:108). According to Andriessen (1999b: 12) the use of
Ringer's lactate as a wound cleanser is particularly beneficial for infected
wounds and wounds with compromised micro-perfusion. It is suggested that
the pH level of Ringer's solution inhibits the growth of certain organisms such
as Pseudomonas aeruginosa. Additionally, Ringer's is free from side-effects
and also provides the cells with essential electrolytes such as sodium,
potassium and calcium which favour cell proliferation and thus healing
(Brychta et al., 1999:55; Andriessen, 2000). However, there is no known
published scientific research to confirm these suggested benefits of Ringer's
lactate as a wound cleanser.
4.5.2.1(h) Sodium chloride
Saline solution (0,9%) is probably the least harmful cleansing agent. It is a
physiological compatible (isotonic) solution, nontoxic and effective in removing
contaminants from the wound surface. Manufacturers frequently recommend
that it be used in conjunction with many of the modern wound management
products (Ferguson, 1988:52; Murray, 1988:75; Tilbury, 1991b:20; Glide,
1992:76; Krasner, 1992:39; Frantz & Gardner, 1994:38; Dealey, 1994:16;
AHCPR, 1994:15; Bux, 1996:307; Miller & Gilchrist, 1997:13; Flanagan,
1997b:61; Gilchrist, 1999).
105
Saline is readily available and relatively inexpensive since it can also be made
at home. The AHCPR (1994:15) provides the following recipe:
o Use 1 gallon (4,5 litres) of distilled water or boil 1 gallon (4,5 litres) of
tap water for 5 minutes. Do not use well (borehole) water or
seawater.
o Add 8 teaspoons (40 ml) of table salt to the distilled or boiled water.
o Mix the solution well until the salt is completely dissolved. Be sure
storage container and mixing utensil are clean (boiled).
o Cool to room temperature before using. This solution can be stored at
room temperature in a tightly covered glass or plastic bottle for up to
one week.
4.5.2.1 (i) Water
Tap water may be used to irrigate and cleanse non-infected wounds. Water
has been used for centuries without any reported detrimental effects and has
always been used in first aid situations to clean wounds (Dealey, 1994:16;
Murphy, 1995:80). Fears concerning bacterial contamination from non-sterile
water supplies and subsequent effects on wounds appear to be unfounded
according to Flanagan (1997b:61). The same author suggests the running of
tap water for a few minutes prior to wound cleansing to flush out any
potentially high levels of bacteria. In fact a study done in Sweden found more
bacterial growth - particularly Pseudomonas aeruginosa - in wounds cleansed
with sterile saline than with tap water (Lindholm 1998:1; Lindholm, Bergsten &
Berglund,1999:10).
Notablyali the research mentioned above has been done in first world or
developed countries. It might therefore be inappropriate to generalize the
findings of these studies to under-developed and/or developing countries such
as South Africa.
106
4.5.2.2 Temperature of cleansing solutions
Research has demonstrated that phagocytic and mitotic cellular activity
significantly decreases at temperatures below 28°C. Lengthy dressing
changes and the application of cool cleansing solutions may reduce the
surface temperature by several degrees (Glide, 1992:74; Dealey, 1994: 18).
It was found that during dressing changes surface temperature could drop so
low that it would take at least four hours before mitotic activity reached a peak
again (Ferguson, 1988:53 citing Johnson, 1986). The ideal wound
temperature to promote healing, has been identified as 37°C (Miller &
Gilchrist, 1997: 19). Cleansing solutions should therefore be stored at room
temperature or may be warmed if cold (Flanagan, 1997b:62).
4.5.2.3 Cleansing techniques
Wounds may be cleansed using either a vigorous or a gentle technique.
4.5.2.3 (a) Vigorous cleansing techniques
Vigorous techniques include placing the wound in a whirlpool. This technique
may be considered for cleansing pressure sores that contain thick exudate,
slough, or necrotic tissue. The immersion of wounds in water with forceful
agitation softens necrotic eschar/tissue and makes them more amenable to
sharp debridement. However, care should be taken to avoid trauma that may
result if the wound is positioned too close to the high-pressure water jets
(Frantz & Gardner, 1994:38).
107
4.5.2.3 (b) Gentle cleansing techniques
Gentle techniques include gently wiping the wound surface with a soft, moist,
gauze dressing or gentle irrigation.
When cleansing by gently wiping the wound surface, care should be taken not
to disrupt granulation tissue. According to Frantz & Gardner (1994:38) when
cleansing the wound in this manner, a "patting" technique is preferable to
rubbing the wound.
Wound irrigation is recommended for wounds with granulation tissue, in which
the goal is to remove surface contaminants and leave granulation tissue
unharmed. Safe and effective pressure sore irrigation pressures range from
four to 15 pounds per square inch (psi). Irrigation pressures below four psi
may not cleanse the wound adequately, and pressures greater than 15 psi
may cause trauma, wash away growth factors and proteases and drive
bacteria into the wound tissue. Irrigation devices that deliver eight psi of
pressure have been found to be more effective in removing bacteria and
preventing infection than is a bulb syringe (Krasner, 1992:39; Frantz &
Gardner, 1994:38; AHCPR, 1994: 15, 16; Leaper, 1998:373). Table 4.3
indicates the irrigation pressures delivered by various clinically available
devices (see Table 4.3, p.99).
TABLE 4.3: Irrigation pressures delivered by various clinical
devices
Device Irrigation ImpactPressure (PSI)
Spray Bottle-Ultra Klenz® a
(Carrington Laboratories, Inc., Dallas TX) 1.2
Bulb Syrinqe"
(Davollnc., Cranston, RI) 2.0
Table 4.3 continues ...
108
TABLE 4.3: Irrigation pressures delivered by various clinical devices
continued ...
,
Device Irrigation ImpactPressure (PSI)
Piston Irrigation Syringe (60-MI) with catheter tip
(Premium Plastics. Inc., Chicago, IL) 4.2
Saline Squeeze Bottle (250-mL) with irrigation cap
(Baxter Health Care Corp., Deerfield, IL) 4.5
Water Pik® at lowest setting (#1)
(Teledyne Waterpik, Fort Collins, CO) 6.0
Irrijet® OS Syringe with tip
(Ackrad Laboratories, Inc., Cranford, NJ) 7.6
35-mL syringe with 19-9auge needle or
angiocatheter 8.0
Water Pik® at middle setting (#3)b
(Teledyne Waterpik, Fort Collins, CO) 42
Water Pik® at highest setting (#5)b
(Teledyne Waterpik, Fort Collins, CO) >50
Pressurized Cannister-Oey-Wash® b
(Dey Laboratories, Inc., Napa, CA) >50
(a) These devices may not deliver enough pressure to adequately cleanse wounds.
(b) These devices may cause trauma and drive bacteria into wounds. They are not
recommended for cleansing soft-tissue wounds.
(AHCPR, 1994:17 citing Beltran, Thacker & Rodeheaver, 1994)
In this study the gentle-cleansing techniques were utilized.
109
4.5.3 Debridement
Debridement involves the removal of devitalized tissue. Moist, devitalized
tissue supports the growth of pathological organisms. The presence of moist,
devitalized tissue and foreign debris provide a culture medium for the growth
of pathological organisms and the ultimate development of a wound infection.
Therefore, the removal of devitalized tissue such as necrotic tissue and
slough, favourably alters the healing environment of a wound (AHCPR,
1994: 13; Frantz & Gardner, 1994:36-37; Vowden & Vowden, 1999a:237).
There are several methods of wound debridement namely: sharp (surgical),
mechanical, enzymatic, autolytic and biological.
4.5.3.1 Sharp (surgical) debridement
Sharp or surgical debridement involves the use of a scalpel, scissors, or other
sharp instrument to remove devitalized tissue. This is the most rapid form of
debridement and the most appropriate technique for removing adherent
eschar and devitalized tissue in wounds. In patients with clotting disorders this
technique is contra-indicated. However, it is essential that those performing
sharp debridement possess the necessary clinical skills and meet
professional licensing requirements (Krasner, 1992:40; Frantz & Gardner,
1994:37-38; AHCPR, 1994:13; Miller & Collier, 1997:18; Vowden & Vowden,
1999b:294). Dealey (1994: 119) supports this view and proposes that surgical
debridement should only be performed by a skilled surgeon because of the
risk of capillary bleeding. Consequently this method might have considerable
cost implications.
110
4.5.3.2 Mechanical debridement
This debridement method is accomplished by placing saline-soaked coarse-
mesh dressings in the wound and allowing the dressings to dry. These
dressings are often referred to as wet-ta-dry dressings. According to Frantz
and Gardner (1994:37) this method is controversial because granulation
tissue also adheres to the dressing and is continually disrupted at dressing
changes. The same authors suggest that wet-to-dry dressings should be
discontinued once the wound begins to granulate. Flanagan (1997b:64)
argues that this technique usually requires frequent dressing changes and in
practice this may encourage the tight packing of wound cavities, which
compromises capillary blood flow, causes discomfort to the patient and
prolongs wound closure. Furthermore, mechanical dedridement can cause
considerable pain to the patient despite the persistent belief that since the
tissue is dead no pain should be experienced (Tong, 1999:338). In view of this
argument, it is proposed that the continuation of this method of debridement
should be reconsidered.
4.5.3.3 Enzymatic debridement
Enzymatic debridement is accomplished by applying topical debridement
agents to devitalized tissue on the wound surface (AHCPR, 1994:13;
Flanagan, 1997b:62). Despite the availability of numerous debriding agents
on the market, Bradley, Cullum and Sheldon (1999) found insufficient
evidence to promote the use of one debriding agent over another. The
different types of enzymes in these agents react differently and require
specific secondary dressings and changing schedules to avoid adverse
reactions such as maceration, inflammation or pain in the wound and
surrounding skin. This debridement method is contra-indicated in patients with
clotting disorders and as with any other method, it should be used cautiously
in patients with infection, cellulitis, cavity wounds, wounds with exposed
nerves, or neoplasms (Krasner, 1992:40; Dealey, 1994:16).
111
4.5.3.4 Autolytic debridement
This debridement method involves the use of synthetic dressings to cover a
wound and allow devitalized tissue to self-digest from enzymes normally
present in wound fluids. Although this method is much more time consuming
than sharp debridement, it is more selective and usually painless for the
patient. Hydrogels, hydrocolloids and transparent film dressings are good
choices to promote autolysis (Krasner, 1992:40). According to Krasner
(1992:40) this method should be used with caution in immuno-suppressed
patients and the Agency for Health Care Policy and Research (1994:15) adds
that this technique should not be used if the wound is infected.
4.5.3.5 Biological debridement
This method of debridement - also known as biosurgery - involves the use of
myiasis (maggots). The larvae used for the treatment are those of Lucilia
sericata or the greenbottle fly. The maggots (or larvae) are specifically bred so
that they do not carry any bacteria. They are introduced onto a wound from a
transparent flask and contained with a net dressing covered with an absorbent
pad. Originally it was suggested that the number of larvae applied should not
exceed 10 per cm2 as this is about the maximum number that can fit into this
area when fully grown. However, according to Thomas, Andrews and Jones,
(1998:524) the maximum number applied is not critical, provided that a vast
excess is not used and the surrounding skin is well protected. Each treatment
is left in place for two to three days. Proponents of the therapy claim that it is
a fast, safe and effective method to treat wounds that need debriding, are
infected or are non-healing (Thomas, Jones, Shutler & Andrews in Miller &
Gilchrist, 1997:21; Courtenay, 1999:177; Vowden & Vowden, 1999a:240). The
main action of the maggots is two-fold. First, they break down dead tissue via
secretion of enzymes.
112
They then ingest this liquefied material along with wound bacteria. According
to Miller and Gilchrist (1997:22) it appears that maggots may stimulate the
production of granulation tissue. Disadvantages of maggot therapy include
aesthetic reasons and local discomfort and itching sometimes caused by their
use (Flanagan, 1997b:65).
The selection of any particular wound debridement method, as discussed
above, should be carefully considered and is dependent on a combination of
factors, namely clinical and practical considerations.
Clinical considerations include:
~ Potential contamination
~ Location of the wound
~ The extent of tissue damage and type of tissue involvement
~ The size of the wound and extent of devitalized tissue
~ The amount of exudate production
Practical considerations include:
~ Time available.
~ Availability of resources.
~ User skill, knowledge base and professional accountability.
~ Cost-effectiveness.
~ The care environment - hospital or community.
~ The patient's wishes (Flanagan, 1997b:63; Vowden & Vowden,
1999a:240).
Finally, the debridement method selected should be appropriate to the
patient's condition and treatment goals.
113
4.5.4 Topical treatment
Over the years, as with wound cleansers, many topical treatment methods
have been used to treat wounds. Some of these methods include the use of
vegetable shortening, egg whites, petroleum jelly and baby powder, urea of
chloroform, antacids, and many more. Cobwebs, clay and wool or linen
bandages sometimes soaked in gum or boiled in water or wine are all old
documented treatment methods. A few of these treatment modalities have
some beneficial properties, however there are no known research studies to
support their use in wound healing (Whittington, 1995:32).
Despite much research and advances in modern wound care, a wide variety
of topical treatments are still being applied to wounds without any recognition
of the need for research-based care. In the following paragraphs some of
these topical treatments, as encountered by the researcher in practice locally,
will be discussed. These topical treatments include the use of antibiotics,
dyes, sugar and essential oils.
4.5.4.1 Antibiotics
A wide range of antibiotics is available in topical form. They are potentially
hazardous and are not always absorbed into the wound. Because of varied
barriers to diffusion in the wound, such as necrosis and pus, antibiotics can
only reach the actual infection deep in the wound with difficulty. Subsequently
there is considerable risk to the patient of sensitization as well as the
development of resistant organisms especially when used routinely over
prolonged periods of time in uninfected wounds as is currently the practice of
many health care professionals (Dealey, 1994:15; Hosein, 1996:389; Brychta
et al., 1999:55). This risk is compounded by the practice of concocting topical
mixtures of different topical and in some cases, crushed or powdered
systemic antibiotics.
114
Another serious disadvantage of prolonged topical antibiotic use is the
occurrence of contact allergies. Furthermore, certain topical antibiotics impair
proliferation and epithelialisation of wounds (Brychta et a/., 1999:55). Because
of the reasons mentioned above the topical use of antibiotics has become
controversial and is no longer recommended.
The AHCPR (1994: 18) however, recommends the use of a two week trial of
topical antibiotics for clean pressure sores that are not healing or are
continuing to produce exudate after two to four weeks of optimal patient care.
The antibiotic should be effective against Gram-negative, Gram-positive and
anaerobic organisms, for example silver sulphadiazine. The agency further
recommends the use of appropriate systemic antibiotic therapy for patients
with bacteraemia, sepsis, advancing cellulitis or osteomyelitis. Systemic
antibiotics are not required for pressure sores with only clinical signs of local
infection (AHCPR, 1994:20).
4.5.4.2 Dyes
Dyes have traditionally been used as astringents to dry macerated skin
around wounds and for their antiseptic properties. A study by Niedner and
Scopf in 1986 (as cited in Dealey, 1994:15) found that 0,5% brilliant green
significantly retarded the formulation of granulation tissue.
Acriflavine is an antimicrobial dye structurally related to acridine. Acriflavine
hydrochloride is a mixture of 3,6-diamino-10-methylacridium-chloride
hydrochloride and 3,6-diaminoacridine dihydrochloride. The acridine
derivatives are slow-acting antiseptics. They are bacteriostatic against Gram-
positive bacteria, less effective against Gram-negative bacteria and ineffective
against spores. Their activity is increased in alkaline solutions and is not
reduced by tissue fluids.
115
Acriflavine has been used in the treatment of infected wounds, burns and for
skin disinfection. However, prolonged treatment may delay wound healing.
Additionally, hypersensitivity to acridine derivatives has been reported
(Reynolds, 1993:782; Hift, 2000).
Crystal violet (Gentian via/et) was once widely used as an astringent. Its use
on broken skin and mucous membranes is now banned in the United
Kingdom following reports that the dye was carcinogenic in animals (Murphy,
1995:78). Despite this, some local health care professionals still continue with
its use on wounds.
Mercurchrome is a mercury compound widely used for its bacteriostatic and
fungistatic properties. There have been several reports of mercury toxicity
following its use as well as anaphylaxis and aplastic anaemia (Tillbury,
1991b:20-21; Dealey, 1994:15). According to Murphy (1995:78) mercury
compounds may cause dermatitis, hypersensitivity and toxicity in epidermal
cells. Considering the associated hazards descibed above, there can be no
justification for its use on wounds.
4.5.4.3 Sugar
Sugar paste has been used in wounds, usually in the form of honey, for many
centuries. More recently sugar pastes have been developed to clean dirty and
malodorous wounds and no toxic effects have been reported (Tillbury,
1991b:21-38; Dealey, 1994:24). It is thought that sugar paste, which has a
high osmotic pressure, exerts its antibacterial effect by competing for the
water present in the bacterial cells (Murphy, 1995:80).
According to Lawrence (1999:155) concentrations of sugars, such as 70%
glucose, are bactericidal to some species but not fungicidal.
116
The same author adds that honey can contain antiseptics such as hydrogen
peroxide, which may further enhance its benefits. Research undertaken by
Cooper and Molan (1999: 161) found that honey with an average level of
antibacterial activity can be effective in preventing the growth of
pseudomonas on the surface of a wound even if the honey were diluted more
than ten-fold by exudation from the wound. As pseudomonas is generally
accepted to be an important pathogen in chronic wounds, it would seem that
the use of honey on wounds in which the presence of pseudomonas causes a
problem, might be a treatment option.
4.5.4.4 Essential oils
Essential oils are thought to interact with the body pharmacologically,
physiologically and psychologically. In order to establish the role of essential
oils in wound care, Baker (1998:355) carried out a literature search of
controlled trials, randomised controlled trials and case studies reported since
1980. Table 4.4 presents examples of reports on the use of essential oils in
wound care.
TABLE 4.4: Examples of the use of essential oils in wound care
~ Myrrh (Commiphora myrrha)
~ Tea tree (Me/aleuca alternifolia)
(Heenan, 1997; Baker, 1998:355)
117
According to Heenan (1997) preliminary findings of trials comparing the
effectiveness of tea tree oil and vancomycin against MRSA, suggest that tea
tree oil may well have a role and that it is probably much safer than
vancomycin.
Price and Price (as cited in Baker, 1998:355) suggest combining the oil with
water and either spraying it on the wound or applying it to the wound on a
non-adherent dressing and securing the dressing in place with cling film to
prevent evaporation of the oil. However, the same authors identify the
following possible adverse effects from the use of essential oils in wound
care:
~ dermal toxicity (some essential oils are skin irritants, usually those
containing high levels of aldehydes or phenols); irritation is usually short-
lived and localised;
~ mucous membrane irritation (essential oils with a substantial phenol
content);
~ phototoxicity (this occurs when the essential oils react with the skin when
exposed to ultraviolet radiation. It may result in erythema,
hyperpigmentation and possibly vesiculation);
~ contact sensitisation (a few oils may cause a reaction after repeat
applications, appearing as redness, irritation and possibly vesiculation).
Despite obvious support for the use of essential oils in wound care from many
health care professionals, it is difficult to find reliable scientific evidence from
which guidelines for good practice could be developed.
118
It is clear from the preceding paragraphs that there is very little, if indeed any
evidence, to support the use of routine topical applications or treatments to
uninfected pressure sores. However, wounds certainly need to be covered
and in the following section wound dressings will be discussed.
4.5.5 Wound dressings
Throughout the centuries humans have always covered their wounds. The
primary function of dressings was for protection. However, in more recent
times, due to the expanded knowledge of the physiology of the healing
process and the recognised influence of dressings on the biochemical and
morphological processes during healing, the function of wound dressings has
gone beyond that of mere protection.
A review of the literature reveals current consensus that the attributes of an
ideal dressing should be the following:
o To protect the wound.
o Not to contaminate the wound with particles and toxic substances.
o Allow gaseous exchange of oxygen, carbon dioxide and water vapour.
o Allow removal without causing trauma.
o Keep the wound warm and moist.
o Assist the removal of exudate and necrotic tissue.
o Be impermeable to micro-organisms.
o Allow monitoring of the wound.
o Be conformable and maidable.
o To be safe to use (non-toxic, non-sensitizing, non-allergenic)
o To be capable of absorbing exudate where necessary (Dealey, 1994:19;
Bennett & Moody, 1995:50; Dale, 1997:12; Miller & Collier, 1997:16; Fox,
1998:87; Culley, 1998:884; Baranoski, 1999).
119
Advances in the development of wound dressings in the last 20 years have
meant that a wide range of different dressing materials has become available
to practitioners. The development of the more recent dressing products is all
based on the fundamental principle of promoting moist wound healing.
Despite the wide variety of dressing products currently available on the
market, new products are constantly being developed. Consequently, the
selection of dressing materials has become increasingly complex as the range
of wound dressing products expands. In an attempt to simplify the selection of
wound management products, dressings are usually classified according to
generic name. However, the classification of wound dressings is also
becoming more complicated since not all products sharing the same
classification work in exactly the same way and manufacturers are beginning
to develop products, referred to as composite dressings, that are a
combination of one or more of the generic groups (Hess, 2000a:26). In the
following paragraphs the major categories of primary dressings, examples,
their indications, advantages and disadvantages will be reviewed.
4.5.5.1 Semi-permeable adhesive film dressings
These dressings are transparent, adhesive-coated, polyurethane, semi-
permeable films (see Table 4.5, p.121).
4.5.5.2 Hydrocolloids (wafers and pastes)
Hydrocolloid dressings consist of a hydrocolloid base containing a variety of
constituents including gelatine, pectin and sodium carboxymethylcellulose in
an adhesive polymer matrix. The hydrocolloid base is hydrophilic in contrast
to the adhesive matrix, which is hydrophobic. The outer layer of these
dressings is a combination of waterproof polyurethane foams and films which
prevents strike-through.
120
TABLE 4.5: Transparent adhesive film dressings
- --T' - ._._~---- --_.. -_ .... - . - -
Examples l Indications I Advantages I Disadvantages
OpSite® 0 Minor burns, lacerations and 0 Impermeable to external fluids 0 Non-absorptive
(Smith & Nephew) abrasions and bacteria 0 Application can be difficult
0 Skin donor sites 0 Transparent/hypo- 0 Cannot be used on wounds
Bioclusive® 0 Pressure sores: stage 1 and allergenic/vapour-permeable with fragile surrounding skin
(Johnson & Johnson Medical) some stage 2 sores 0 Conformable or infected wounds
0 Secondary dressing in certain 0 Can be left in place for up to
Hydroflim® situations seven days
(Hartmann) 0 Post-operative wounds 0 Does not require secondary
0 Entrance sites of peripheral dressing
Tegaderm® and central intra-venous lines 0 Reduces surface friction
(3M)
0 Reduces pain in superficial
wounds
0 Allows easy tracing of the
wound
(Willey, 1992:44,45; Dealey, 1994:225,226; Erwin-Toth & Hocevar, 1995:48; Walker, 1996:36,37; Dale, 1997:13; Thomas, 1997c; Baranoski, 1999; Brychta
et el., 1999:102,103)
121
Montero, Cedeno, Oreamuno and Valverde (1999:16) compared hydrocolloid
dressings (Comfeel™) and traditional gauze dressings in the treatment of
pressure sores. The two dressings were compared in terms of the rate of
wound healing and cost over an eight-week period. Results of the study
showed that the healing time for pressure sores treated with the hydrocolloid
dressings were shorter than those treated according to the traditional method.
Furthermore the cost of treatment with the hydrocolloid (Comfeel™) was
significantly lower compared with the traditional treatment. The results of this
study confirm the findings of a similar study by Krysiak, Wolowicka and Dyk
(1998:20) (see Table 4.6, p.123).
4.5.5.3 Hydrogels
Most of these products share a common basic structure consisting of about 2-
3% of a gel-forming polymer such as carboxymethylcellulose, modified starch
or sodium alginate, together with 20% propylene glycol as a humectant and
preservative. The balance, about 80%, consists of water. Most hydrogels are
similar in appearance but laboratory tests have indicated that their fluid
donating properties can vary considerably. In addition some products are also
able to absorb a limited amount of fluid from exuding wounds (Thomas,
1997c). Currently three forms of hydrogels are available:
~ Amorphous hydrogels - packaged in tubes, foil packets and spray bottles.
~ An impregnated-gauze hydrogel - an amorphous hydrogel impregnated
into a gauze pad.
~ Sheet hydrogels - consisting of a gel supported by a thin fibre mesh
(Hess, 2000b).
122
TABLE 4.6: Hydrocolloids
Examples ! Indications Advantages i Disadvantages
Comfee/® 0 Partial-thickness wounds 0 Waterproof and impermeable 0 Not recommended for wounds
(Coloplast) 0 Pressure sores: superficial to external bacteria and with heavy exudate, sinus
stage 3 and some approved contaminants tracts, infections; wounds that
DuoDerm® clean stage 4 0 Conformable and easy to expose bone or tendon; or
(Convatec) 0 Wounds with necrosis or apply wounds with fragile
slough 0 Support autolytic debridement surrounding skin
Granuflex® 0 Wounds with mild to moderate 0 Minimally to moderately 0 May be difficult to remove and
(Convatec) . exudate absorptive may leave residue on the skin
0 Protect granulation and newly 0 Not transparent
Tegasorb® formed epithelial tissue 0 Can melt at the edges, soften
(3M Health Care) 0 Colour change indicates when and wrinkle with wear and
to change dressing movement
Hydrocol/®
0 Can be used with 0 May curl or "seep" under edge
(Hartmann) compression for the treatment 0 Unpleasant odour from gelled
of venous ulcers dressing at dressing change
0 Create a moist environment 0 Can cause sensitivity to the
which promotes healing and is adhesive
helpful for pain relief in the
treatment of arterial leg ulcers,
thus reducing the need for
analgesics
0 No secondary dressing is
needed
0 Help contain wound odour
0 Last long, thus saving money
and nursing time _ I
(Fowler, Cuzzell and Papen, 1991:63, 64; Willey, 1992:44, 45; Dealey, 1994:198, 210; Erwin-Toth & Hocevar, 1995:48; Maklebust, 1995:49; Hofman,
1996:68; Dale, 1997:13; Krysiak, Wolowicka & Dyk, 1998:21; Baranoski, 1999; Brychta et al., 1999:102,103)
123
In 1996 Colin, Kurring, Quinlan and Yvon (1996:444) compared the
performance of a hydrogel (Intrasite Gel™) and a dextranomer paste
(Debrisan Paste™) in the management of sloughy pressure sores in the
hospital environment. They reported that the hydrogel and the paste
performed to a similar standard in terms of debridement of non-viable tissue.
At day 21, however, the median reduction in wound area was 35% in the
hydrogel group compared with 7% in the dextranomer paste group.
Furthermore at each assessment the hydrogel was found to be easier to apply
than the dextranomer paste. The hydrogel was also found to be associated
with less pain.
A subsequent study by Bale, Banks, Hageistein and Harding (1998:65)
compared the efficacy of two hydrogel dressings (Intrasite Gel™ and
Sterigel™) in the debridement of necrotic pressure sores. This randomised,
controlled, assessor-blind, clinical trial involved 50 patients whose wounds
were assessed weekly using computerised wound analysis for four weeks or
until debrided. The researchers concluded that there were no statistically
significant differences in comfort, wound odour, surrounding skin condition or
time to debridement between the two groups (see Table 4.7, p.125).
4.5.5.4 Absorption or filler dressings
Four preparations in this category include:
~ Copolymer starch dressings
~ Dextranomers
~ Calcium alginates
~ Hydrofibre dressings
124
TABLE 4.7: Hydrogels
Examples I Indications Advantages I Disadvantages
/ntraSite Ge/® 0 Partial-and full-thickness 0 Provide a moist environment 0 Most require secondary
(Smith & Nephew) wounds (stage 2, 3, and 4 0 Soothing and cooling dressing
pressure sores) 0 Fill dead spaces 0 Not used for heavily exuding
Granuge/® 0 Wounds with necrosis or 0 Promote autolytic wounds
(Convatec) slough debridement 0 May dry out, then adhere to
0 Burns and tissue damaged by 0 Provide minimal to moderate wound bed (Sheet form in
NU-Ge/® radiation absorption particular)
(Johnson & Johnson Medical) 0 For softening of eschar 0 Conform to wound bed 0 May macerate surrounding
0 For debridement and at all 0 Transparent to translucent skin
stages of healing up to the 0 Many are non-adherent 0 If the incorrect depth of
formulation of granulation 0 Can be used when infection is dressing is used, the wound
tissue present may dry out around the edges
0 For filling dead spaces within 0 Easy to apply I
a wound 0 Available in sheets and gels
~----_. - -_. __ .- I
(Willey, 1992:44,45; Dealey, 1994:14; Erwin-Toth & Hocevar, 1995:49; Maklebust, 1995:49; Walker, 1996:38, 39; Thomas, 1997c; Heenan, 1999:72; Hess,
2000b)
125
The majority of these dressings are a non-woven composite of calcium
alginate fibres, a cellulose-like polysaccharide. It is a highly absorptive
dressing which is manufactured from brown seaweed and forms a soft gel in
the presence of wound exudate.
Another dressing in this category is the hydrofibre dressing which consists of
a soft non-woven fibre of sodium carboxymethylcellulose. The hydrofibre acts
by direct absorption of fluid into the fibres themselves. Conventional
dressings, including alginates, absorb liquids into the interstitial space
between the fibres. Direct absorption into the fibres greatly increases the fluid-
handling capacity of the dressing per unit weight of dressing material
(Robinson, 2000:32). A study by Armstrong and Ruckley (1997:344) which
compared a hydrofibre dressing (Aquacel™) with a widely used alginate,
found that the hydrofibre dressing achieved significantly longer wear times
than the alginate. This translated into significant savings in terms of nursing
time and overall cost of wound care (see Table 4.8, p.128).
4.5.5.5 Semipermeable polyurethane foam dressings
Polyurethane foam dressings have a hydrophilic action that provides a low
adherent wound contact layer. Some of these dressings have moisture-
vapour-permeable backings which are hydrophobic, preventing vertical strike-
through. The exudate is absorbed horizontally and once the dressing is
saturated, exudate becomes visible at the dressing edges as lateral strike-
through. Although the various polyurethane foam dressings are classified
under one title, their construction varies considerably.
In 1995 Bowszyc, Silny, Bowszyc-Dmochowska, Kazmierowski, Ben-Amer,
Garbowska and Harding (1995: 110) conducted a clinical trial in Poland during
which the efficacy of a polyurethane foam dressing (Lyofoam™) and a
hydrocolloid dressing (Granuflex™) was compared.
126
They found that both dressings were comfortable, caused little pain on
removal and were easy to apply. However the same researchers reported that
the foam dressing was significantly easier to remove from the wound than the
hydrocolloid dressing.
In a subsequent study by Bale, Squires, Varnon, Walker, Benbow and
Harding (1997:463) in which a polyurethane dressing (Allevyn Adhesive™)
and a hydrocolloid dressing (Granuflex™) were compared in the management
of pressure sores, they confirmed the results of the Polish study.
127
TABLE 4.8: Absorption or filler dressings
--
Examples ! Indications Advantages Disadvantages
Ferris PolyMem®* 0 Wounds with moderate to 0 Easy to apply and remove 0 Require secondary dressing !
(Ferris Mfg.Corp.) large amounts of exudate 0 Absorb up to 20 times their 0 Not recommended for dry or
(donor sites, leg ulcers, weight in drainage lightly exuding wounds
Debrisan®** pressure sores and fungating 0 Fill dead space 0 Can dry wound bed
(Johnson & Johnson Medical) wounds) 0 Support autolytic debridement 0 Will adhere to wound bed if
0 Wounds with combination in presence of exudate there is insufficient exudate
Algi DERM®*** exudate and necrosis 0 Alginate dressings have 0 Produce a greenish gel which
(Convatec) 0 Wounds that require packing haemostatic properties can be misinterpreted as a
and absorption 0 They can be used on infected sign of wound infection
Kaltostat®*** 0 Infected, exuding wounds wounds
(Convatec) 0 They provide a moist
environment which relieves
Sorbsan®*** pain
(Maersk)
0 They are ideal for use in
cavity wounds
Tegagen®***
0 They are bio-degradable
(3M Health Care)
Sorbalgon®"**
(Hartmann)
Aquacel® Hydrofibre****
(Convatec) ._--- -
(Willey, 1992:45; Dealey, 1994:217, 228, 229, 234, 235; Erwin-Toth & Hocevar, 1995:49, 50; Maklebust, 1995, 49; Walker, 1996:37, 38; Convatec, 1996;
Dale, 1997:13; Thomas, 1997c; Heenan, 1998:37,38; Heenan, 1999:72; Brychta et al., 1999:97,98; Robinson, 2000:32; Thomas, 2000:58,59)
Copolymer starch dressings
Dexlranomers
Calcium alginate
Hydrofibre dressings
128
However, an additional finding of Bale and eo-workers was that the
absorbancy of the poylurethane foam dressing (Allevyn Adhesive™) was
significantly better than that of the hyrdocolloid dressing.
Another multi-centre study which also compared the performance of a
polyurethane dressing (Allevyn Adhesive™) to a hydrocolloid dressing
(Granuflex™) in the management of stage 2 and 3 pressure sores, confirmed
the findings of the two studies mentioned above. Moreover, they reported that
in contrast to the hydrocolloid dressings (Granuflex™), the polyurethane
dressings (Allevyn Adhesive™) were not associated with damage to the
wounds or the surrounding skin (Shutler, Stock, Harding, Squires, Wilson,
Vernon, Walker, Ridley and Benbow, 1995) (see Table 4.9, p.130).
4.5.5.6 Odour absorbing dressings
These low adherent dressings are combined with either activated charcoal
cloth or activated carbon in order to reduce wound odour. The deodorising
agent is combined with various other materials including alginates, foams or
low-adherent wound contact layers (see Table 4.10, p.131).
4.5.5.7 Gauze impregnated dressings (Tulle Gras)
Open mesh, cotton, rayon, viscose or gauze impregnated with white or yellow
soft paraffin, antiseptics or antibacterial agent (see Table 4.11, p.132).
4.5.5.8 Iodine-containing dressings
These are knitted viscose dressings impregnated with 10% povidone-iodine in
a water-soluble polyethylene glycol base (see Table 4.12, p.133).
129
TABLE 4.9: Semipermeable polyurethane foam dressings
Examples I Indications Advantages DisadvantagesI
Alievyn® 0 Partial- and full-thickness 0 Non-adherent 0 Require secondary dressing,
(Smith & Nephew) wounds with minimal to 0 Conformable (not Allevyn tape or net (except Tielle®
moderate exudate (pressure Cavity®) and Allevyn Adhesive®)
Allevyn Adhesive® sores, venous leg ulcers and 0 Manage light to moderate 0 Not for use with dry eschar,
(Smith & Nephew) burn wounds) amounts of exudate wounds with no exudate, or
0 Secondary dressing for 0 Easy to apply and remove wounds with sinus tract
Tielle® wounds with packing to 0 May be used under unless packed
(Johnson & Johnson Medical) provide additional absorption compression 0 May adhere if exudate
0 Around drainage tubes 0 Can be used on wounds that becomes reduced
Lyofoam® have surrounding body hair 0 Allevyn Cavity® does not
(Acme United 0 Can be used on infected conform to cavity shape and
Corporation) wounds (not Tielle®) the available sizes may be
0 Can be cut to shape/size of inappropriate for cavity size
Allevyn Cavity® wound (not Allevyn Cavity®)
(Smith & Nephew)
0 Lyofoam® is highly permeable
to moisture vapour and is also
used as low adherent
dressing for minor injuries and
other wounds in the final
stages of healing
(Doughty, 1991:49; Willey, 1992:44,45; Dealey, 1994:190, 191,192,218,219,237,238; Erwin-Toth & Hocevar, 1995:50; Maklebust, 1995:49; Bennett &
Moody, 1995:55, 56; Walker, 1996:36,39; Thomas, 1997c; Dale, 1997:13, 14; Thomas, 1997b:482; Smith & Nephew, 1997:4-7; Culley, 1998:884; Heenan,
1999:72; Baranoski, 1999)
130
TABLE 4.10: Odour absorbing dressings
Examples ! Indications Advantages ! Disadvantages
Actisorb PluS® 0 Malodorous wounds such as 0 Effective method of controlling 0 Cannot be cut to size
(Johnson & Johnson Medical) fungating carcinomas', leg odour (Actisorb PluS®)
ulcers or infected wounds with 0 Simple to use 0 May adhere to wound if used
Lyofoam C® low to moderate exudate 0 An effective combination of as a primary dressing ,
(Seton Health Care) dressing and charcoal (Actisorb PluS®)
(Lyofoam C ®) 0 Absorb less exudate than
ordinary Lyofoam® (Lyofoam
C®)
0 Actisorb PluS® is contra-
indicated for patients sensitive
to nylon
0 Lyofoam C ® is contra-
indicated for wounds with dry
eschar
0 Ineffective when moist ,
I
(Dealey, 1994:189, 190, 219, 220; Bennett & Moody, 1995:63, 63; Thomas, 1997c; Dale, 1997:13, 14; Thomas, 1997b:482; Thomas et al., 1998; Heenan,
1999:72)
131
TABLE 4.11: Gauze impregnated dressings
Examples iI Indications Advantages i Disadvantages
Jelonet® 0 Superficial wounds 0 Do not adhere to wound bed 0 Need frequent changing
(Smith & Nephew) non- (abrasions, lacerations and 0 Medicated tulle may reduce because threads may become
medicated leg ulcers) the risk of infection incorporated into granulation
0 Wounds in the later stages of (BactigraS® contains tissue
!
Ba ctigraS® healing (lightly exuding chlorhexidine which is active 0 Require secondary dressing
(Smith & Nephew) medicated wounds) against a wide variety of 0 Antimicrobial agents in
0 Medicated tulle dressings may bacteria) medicated tulle may be
Grassolind® be effective to counter and/or 0 Maintain a moist wound harmful to fibroblasts
(Hartmann) non-medicated treat infection surface 0 The sticky residue remaining
on the skin and wound is
often difficult to remove
0 May adhere to the wound if
--_._-----~ dressing dries out ---
(Krasner, 1992:38; Krasner, 1995:47; Bennett & Moody, 1995:52; Thomas, 1997c)
132
TABLE 4.12: Iodine-containing dressings
i
Examples I Indications Advantages iI Disadvantages I!
Inadine® (Johnson & Johnson 0 Shallow infected wounds, 0 Has a broad spectrum 0 Little absorptive capacity
Medical) superficial burns, leg ulcers antiseptic affect 0 Some patients may develop a
and on skin areas where 0 Can be used prohpylactically sensitivity or be allergic to ,
orthopaedic pins protrude or to treat a wide range of povidone or povidone iodine
I
0 Contaminated traumatic bacterial, protozoal and fungal 0 As iodine can be absorbed I
I
injuries infections through the tissues, these
0 Easy to use products should not be
applied during pregnancy,
lactation and to patients with
thyroid disorders
(Dealey, 1994:210,211; Bennett & Moody, 1995:52; Krasner, 1995:47; Dale, 1997:13, 14; Thomas, 1997b:482; Lawrence, 1998b:422; Lawrence, 1998a:332;
Heenan, 1999:72)
133
4.5.5.9 Gauze dressings
These are dressings made from woven cellulose (cotton and rayon fibres)
(see Table 4.13, p.135).
Although some practitioners still use cotton wool as a secondary dressing and
to clean wounds with, its use is not recommended (See Section 3.3.2.5). As
such it is not included in any category of wound dressing.
From the preceding paragraphs it is evident that no single dressing is suitable
for the management of all types of wounds, and few are ideally suited to the
treatment of a single wound during all the stages of the healing trajectory.
Therefore, the product that best meets the needs identified after a thorough,
holistic assessment of the patient and the wound should be selected.
Acceptability, availability and cost are additional factors to be considered in
the process of dressing selection.
The cheapest acceptable and available dressing that will be effective in
meeting the identified needs should be selected, bearing in mind the extra
costs of more frequent renewal and the need for secondary dressings.
Nonetheless, if based on the evidence of sound economic evaluation, the
selection process may be greatly enhanced thereby providing high quality
wound care whilst achieving significant cost savings.
134
TABLE 4.13: Gauze dressings
.
Examples Indications Advantages i Disadvantages
Numerous products available 0 Exudative wounds 0 Readily available and 0 Will disrupt wound healing if
0 Wounds with dead spaces, relatively inexpensive allowed to dry
tunneling or sinus tracts 0 Can be used with appropriate 0 Require secondary dressing
0 Wounds with combination solutions such as gels, normal 0 If tightly packed it may
exudate or necrotic debris saline or topical antimicrobials compromise blood flow and
to keep wounds moist, delay wound closure
provided the dressings are 0 Moisture from gauze
kept moist dressings may macerate the
0 Can be used in conjunction surrounding skin
with other dressings 0 Require frequent dressing
0 Can be used on infected changes which is time
wounds consuming
0 Wet-to-damp dressings 0 Cellulose dressings may
support autolytic debridement disintegrate and particles can
and absorb exudate and be introduced into the wound
contain bacteria in the gauze, which may elicit an
which are removed when the inflammatory response, the
dressing is changed formation of fibrous tissue and
0 Can be used for gentle hypertrophy
cleansing of wounds
(Krasner, 1991:49; Willey, 1992:44,45; Krasner, 1992:38; Frantz & Gardner, 1994:39; Maklebust, 1995:49; Erwin-Toth & Hocevar, 1995:51; Krasner, 1995:47;
Walker, 1996:38; Thomas, 1997b:479; Lawrence, 1997:46; Heenan, 1999:72)
135
4.6 ADJUNCTIVE THERAPY
Several adjunctive therapies claim to enhance pressure sore healing. These
include the following: negative-pressure therapy; radiant heat therapy;
electrotherapy; hyperbaric oxygen; infrared, ultraviolet and low energy laser
irradiation; ultrasound; miscellaneous topical agents (such as vitamins,
hormones and cytokine growth factors) and systemic drugs other than
antibiotics such as vasodilators, serotonin inhibitors and fibrolytic agents
(Undersea and Hyperbaric Medical Society (UHMS), 1992; AHCPR, 1994:18;
Baxandall, 1996:49; Moon, 1998; Sussman, 1998; Banweil, 1999:79; Youn,
1999; Barry, 2000:52; Mcculloch, 2000; Kloth et al., 2000).
Most of these adjunctive therapies have additional cost implications and are
not suited to routine use in community settings. Since none of them were used
in this study a detailed discussion of these adjunctive therapies falls beyond
the scope of this review.
4.7 CONCLUSION
This chapter provided an overview of the principles of pressure sore
management. The following chapter will review economic evaluation
approaches of pressure sore management.
136
CHAPTER F~VE
IEco01lom~cevaluation of pressure sore management
137
5.1 INTRODUCTION
Robinson (1993a:671) describes economic evaluation (or economic appraisal
as it is sometimes referred to) in health care, as a range of techniques that
may be used to assemble evidence on the expected costs and consequences
of different procedures or programs. Economic evaluation in the health sector
has become increasingly significant. This fact is underscored by the high
treatment cast of pressure sores (Colin, 1995:65; Torrance & Mayior,
1999:27).
A review of the relevant literature reveals four main economic evaluation
approaches in health care: cost-minimization analysis, cost-benefit analysis,
cost-utility analysis and cost-effective analysis (Spilker, 1991:307; Robinson,
1993a:671; Brooks & Semiyen, 1997:492-493 and Manheim, 1998:149). A
brief discussion of these evaluation approaches is provided in the following
paragraphs.
5.2 COST -M~NIMIZATIONANALYSIS
Cost-minimization analysis is defined as the analysis and comparison of costs
for two (or more) interventions shown (or believed) to be equivalent in
outcomes or consequences. Therefore, the objective of this type of analysis is
to identify the least expensive way to achieve the same therapeutic outcomes
that need not be measured. An example of this would be alternative forms of
delivery in maternity services such as at home or in hospital, but the outcome
is the same, live births (Spilker, 1991:303; Robinson, 1993b:726; Brooks &
Semiyen, 1997:492). Since the outcome of any pressure sore treatment
method is debatable, this type of analysis is unlikely to be appropriate for this
particular study.
138
5.3 COST-BENEFiT ANALYSIS
Spilker (1991:303) defines this economic evaluation approach as the
simultaneous measurement of costs and consequences of treatment, where
both are expressed in terms of money. The cost-benefit analysis approach
has been criticized for its use of monetary measures, especially with value
outcomes. For example, outcomes such as improved patient well being or
acceptability of a treatment method, are difficult to translate into a monetary
value (Robinson, 1993a:671-672; Brooks, 1997:136; Brooks & Semiyen,
1997:493).
In light of this limitation and the fact that no comprehensive cost-benefit
studies of pressure sore management have been reported in the literature, a
cost-benefit analysis approach is not suitable for this study.
5.4 COST-UTILITY ANALYSIS
Cost-utility analysis is defined as the simultaneous measurements of costs
and consequences of treatment. Measurements of quality of life
consequences are usually made in terms of preference for one intervention
over another. Price (1996: 139) describes quality of life as a multi-dimensional
construct, which can be measured via physical, psychological and social
aspects of well-being and/or function as perceived by patients and/or
observers.
According to Spilker (1991:303), the objective of a cost-utility analysis is to
choose the least expensive approach to achieve a set standard gain,
expressed in terms of artificial units such as quality adjusted life years
(QALYs).
139
A Quality-adjusted life-year (QAl Y) is constructed from a scale, usually
normalised from zero to one, on which is placed a variety of health states. The
endpoints are typically, 'full health' and 'dead'. If a patient's health state is 0.7
before treatment and the patient is restored to full health after treatment, a
gain of 0.3 QAl Ys would accrue for each subsequent life-year (Pritchard,
1996:148). Brooks and Semiyen (1997:493) propose that the pressure sore
field would appear to be a candidate for cost-utility analysis, since pressure
sores can have serious implications for quality of life. However, some
problematic issues are involved, for example, it would be necessary to
distinguish between changes in the quality of life attributable to the treatment
of the pressure sore, from changes due to treatment for medical conditions.
There is universal agreement amongst scholars that the most important
source of information about the impact of a particular disease or disorder on
the quality of life, is the patient (Spilker, 1990:16; Dazord & Gerin, 1994:4;
Reid: 1996:142). Given this fact, the majority of questionnaires and scales
used to assess quality of life, originate with the patient's perspective rather
than that of the experts, as research has shown that the ratings of doctors and
other health-care staff differ substantially from those of patients (Horton,
1995:2; Price, 1996:139). However, there are some circumstances in which
patients are unable to rate the quality of their own lives such as those
suffering from age-related dementia or Alzheimer's disease. In these cases,
the debate continues about who should act as proxy rater, and about the
validity, and indeed the meaningfulness, of such ratings (Downie, 1999:381;
Harding, 2000: 188).
In the light of the above it is evident that a formal assessment of quality of life,
as an endpoint in this study, will be inappropriate. However, as one of the
objectives of this study were to assess the acceptability of pressure sore
treatment methods, the researcher implicitly assessed one of the dimensions
of quality of life.
140
5.5 COST-EFFECTIVE ANALYSIS
This type of analysis is defined as the simultaneous measurement of costs
and consequences of treatment. Costs are measured in terms of money, and
effectiveness is measured in terms of obtaining a specified objective. Thus,
the objective of a cost-effectiveness study is to choose the least expensive
approach to achieve a set standard of gain, expressed in terms of a
meaningful medical unit. Cost-effective results are expressed as a ratio of
casts to benefits (Spilker, 1991 :302; Robinson, 1993a:672; Robinson,
1993c:793; Brooks, 1997:136; Brooks & Semiyen, 1997:492).
5.6 CONCLUSION
In this study the cost of treatment method was measured in terms of money
and the effectiveness of the treatment method was measured in terms of
reduction in wound size, over a time period of six weeks.
141
Research Me1thodlo~ogy
142
6.1 INTRODUCTION
In the following chapter the research methodology will be explicated in the
light of the advantages it offers this study. Included will be a review of the
instrument used in this study.
6.2 PURPOSE OF THE RESEARCH .
The purpose of the study was to compare the current wound care
management method with a more advance.d wound care management
method in the treatment of patients with pressure sores in the community.
6.2.1 Research objectives
The objectives of this study were to:
~ Compare the cost-effectiveness, with regard to treatment cost and rate of
healing, of current wound care management to advanced wound care
management in the treatment of pressure sores in the Bloemfontein
community of the Free State Province, over a six week period.
~ Assess the acceptability of these treatment modalities - to patients with
pressure sores and their caregivers in the community over a six week
period - in terms of (i) ease of application, (ii) comfort of the dressing, (iii)
durability of the dressing over the period of application and (iv) ease of
removal.
143
6.3 RESEARCH DESIGN
Of the nine main experimental designs available to the nurse researcher, as
identified by Burns and Grove (1993:317-323), a prospective, randomised
clinical trial was best suited to the phenomenon under investigation.
This experimental design may be further classified as an open-label clinical
trial since both the researcher and the patients knew the nature of the
treatment. As patients were placed into two treatment groups and data
obtained from each group compared, the design could additionally be
classified as a cross-sectional clinical trial as described by Spilker (1991:28).
In support of the chosen design the following was noted. Experimental
designs provide a significant amount of control in order to examine causality
more closely. It has also been proposed that this technique should be used to
examine areas of nursing practice, such as comparing traditional nursing care
practices with newer techniques (Burns & Grove, 1993:323).
6.4 POPULATiON
The population of this study consisted of patients with uninfected pressure
sores, living in the Bloemfontein community which included the following
areas:
All areas within the old municipal boundaries of Bloemfontein; Bainsvlei- and
Bloemspruit smallholdings, and Mangaung (Van Heerden, 1999).
144
6.4.1 Patient recruitment
Patients were recruited via referrals from primary health care clinics,
community health care workers, social workers and other health care
professionals practising in the community. Several patient recruitment
strategies, as described by Spilker (1991:87), were used to increase patient
recruitment. They included the following:
~ Communicating with colleagues directly, via e-mail and telephone,
requesting referrals.
~ Speaking at formal and informal professional meetings requesting
referrals.
~ Placing notices in places where colleagues and/or patients would see
them.
~ Placing advertisements in local newspapers (see Appendix 1).
Once recruited, inclusion and exclusion criteria were used to enroll patients
into the study.
6.4.2 lnclusion criteria
The following criteria were used to enroll patients:
~ Patients in the community aged 18 years or older with a clinically
uninfected Stage 2, 3 or4 pressure sore.
~ Patients, or their guardians, who gave informed consent.
~ Patients who were willing and able to comply with the treatment.
6.4.3 Exclusion criteria
The criteria used to exclude patients from the study were:
~ Patients aged younger than 18 years.
~ Patients or their guardians, who declined to participate in the study.
145
~ Patients with clinically infected wounds (see Chapter 4, Section 4.3.1.9).
~ Patients with a Stage 1 pressure sore.
In establishing the above criteria the following were considered.
~ Most clinical trials are conducted on adults between 18 and 65 years of
age (Spilker, 1991:658). Furthermore, according to the Child Care Act,
number 74 of 1983, Section 39(4), persons of 18 years and older are
considered competent to consent independently, without the assistance of
a parent or guardian, to any medical treatment (South Africa, Act No. 74,
1983). Therefore, patients below the age of 18 years were excluded.
However, since pressure sores are generally associated with the elderly,
no upper age limit was specified in the inclusion criteria.
~ In accordance with the worldwide accepted Good Clinical Practice
Guidelines as described by Spilker (1991 :450), only patients, or their legal
guardians, who gave informed consent were included in the study.
~ As infected wounds may require additional treatment such as systemic
antibiotic therapy, and are therefore not comparable to uninfected wounds
in terms of treatment cost and healing rate, these wounds were excluded
from the study.
146
~ According to the Sterling Pressure. Sore Severity Scale, Stage 0
(described as no clinical evidence of a pressure sore) and Stage 1
(described as discoloration of intact skin) sores, do not involve skin loss or
damage to the dermis and/or epidermis (Waterlow, 1996:54). As such they
do not allow for objective measurement of the rate of healing as in wounds
classified as Stage 2, 3, or 4, and were therefore excluded from the study.
6.4.4 Withdrawal procedure
Any patient who interrupted the trial treatment for longer than one week, either
consecutively or in total, was withdrawn from the study. Patients who did not
respond to the management method were withdrawn from the study only at
the point where it became necessary to change .the treatment on clinical
grounds. Furthermore, patients could withdraw or be withdrawn for the
following reasons:
~ At the patient's own request;
~ If the patient moved from the geographical area;
~ Developed a concurrent illness and was unable or unwilling to continue in
the trial;
~ Developed a wound infection;
~ Death.
6.5 SAMPLING METHOD
Sampling was carried out by randomly allocating 58 eligible patients with a
Stage 2, 3 or 4 clinically uninfected pressure sore(s), into an equally sized
control- and experimental group. Randomisation was done by stage and
according to a computer generated randomisation list provided by the
Department Biostatistics at the University of the Orange Free State.
147
If a patient had more than one pressure sore, all sores were treated with the
same treatment modality. However, only one sore was chosen at random for
inclusion in the study and it was on the basis of this sore's SPSSS
classification, that randomisation of treatment modality occurred. In order to
select one sore at random, the sores were number.ed from top (superior) to
bottom (inferior), left to right and a random number selected from a random
number table.
The sample size was derived from an extensive and exhaustive literature
review of community-based wound care studies. Unlike institution-based
studies, community-based studies do not allow for larger sample sizes without
certain implications (Banks & Bale, 1994:304). These implications refer to
several practical issues that arise from larger studies, such as variable control
and the financial implications of extensive community-based studies that
require additional skilled field workers.
In view of the above and the documented success of smaller comparable
studies by Bale, Squires, Varnon, Walker, Benbow and 'Harding (1997: 463)
and Bale, Banks, Hageistein and Harding (1998:65), the researcher decided,
in collabaration with the Department of Biostatistics at the University of the
Orange Free Sate, that a sample size of at least 40 patients was a statistically
adequate number.
6.6 TREATMENTMODAUTY
Two pressure sore treatment modalities were used namely: an advanced
wound care management method .and the cum;mtly used management
method (see conceptual definitions, Section 1.7). Patients allocated to the
experimental group were treated with the advanced method and patients
allocated to the control group were treated with the currently used method.
148
6.6.1 Advanced wound care management
This management method was based on the principle of the research-based
concept of moist wound healing (see Sections 3.2.3 and 4.5.5). All patients in
the experimental group were treated exclusively with Smith & Nephew™
wound care products. The procedure was conducted in the following manner:
The peri-wound area was cleansed with a gentle, hypoallergenic soap
(Protex™ factor 13) and water to remove any exudate and transient micro-
organisms from the surrounding skin. The surrounding intact skin was dried
with sterile gauze as contained in the Smith & Nephew Surgipak™.
The wounds were then aseptically cleansed with warm (approximately 37oC),
sterile, physiological saline as contained in Adcock Ingram's Sab-Saline™
plastic containers (see Sections 4.5.2.1 and 4.5.2.2).
The saline was warmed as recommended by Bux and Malhi (1996:307), by
placing the individual single dose 30 ml plastic ampules of saline solution in a
jug of water heated to 40 DC, as measured by a standard. thermometer, for 30
minutes. Assurance was obtained from the manufacturer that this method of
heating would not have a deleterious effect on the saline or the container
(Healy, 2000). The heated saline ampules were then placed and transported
in an insulated container to maintain a temperature of approximately 37oC. A
gentle cleansing technique was used by either irrigation, if the wound had
delicate granulation tissue, or by gently patting the wound bed.
3 Protex™ factor 1 is hypoallergenic and tested by cermatoloqists. It provides mild
antibacterial protection for delicate and sensitive skin, and is especially recommended for
children and people with sensitive skin (Colgate-Palmolive, 1999).
149
Irrigation was accomplished by using a sterile 20-ml syringe and 18-gauge
needle thereby delivering an irrigation pressure of approximately eight pounds
per square inch (psi) - an irrigation pressure considered by the AHCPR
(1994: 15) to be safe and effective for wound cleansing (see Section 4.5.2.3
[b]). Where any non-viable tissue was oresent on the surface of the wound
requiring debridement, a thin layer of IntraSite ™ gel was applied on the
wound bed and covered with either Allevyn ™ Cavity, in the case of cavity
wounds, or Allevyn ™ non-adhesive, hydrocellular sheets or Allevyn ™
Adhesive.
If the wound was granulating and no non-viable tissue was present at the
surface, then Allevyn ™ non-adhesive, hydrocellular sheets or Allevyn ™
Adhesive were applied directly to the wound. Transparent OpSite Flexigrid™
dressings were applied to Stage 2 epithelialising wounds or blisters.
OpSite Flexigrid™ was also used as a secondary dressing to secure
Allevyn ™ non-adhesive dressings. All the selected dressings were applied to
the wounds strictly according to the manufacturer's instructions (see Appendix
2 for a list of the Smith & Nephew™ products used in the study as well as
instructions for use and contra-indications).
6.6.2 Currently used wound care management
The procedure was carried out in the following manner:
The peri-wound area was cleansed with gentle, hypoallerqenic (Protex™
factor 1) soap and water to remove' any exudate and transient micro-
organisms from the surrounding skin. The wound was then aseptically
cleansed and covered with the available wound care materials and/or
methods as used on that particular patient at that time by the patient or
primary caregiver.
150
These materials included some advanced or modern dressings, however any
Smith & Nephew™ products were excluded. These materials and/or methods
are listed in Appendix 3 along with references to the relevant sections in the
literature review where they are discussed.
In order to avoid cross-contamination and subsequent wound infection, the
researcher maintained strict adherence, in both treatment modalities
throughout the entire study, to the basic principles of asepsis and infection
control, as recommended by the Agency for Health Care Policy and Research
(1994:20) (see Appendix 8).
Similarly, throughout the study, the researcher provided continuous education
and encouraged all patients and caregivers to adhere to the measures for
pressure reduction, daily skin examination and intermittent pressure relief
techniques as described in the Clinical Practice Guidelines by the AHCPR
(1994:1-10) (see Appendix 8). Additionally the researcher attempted to, where
possible, to address those identified factors that could delay wound healing.
6.6.3 Period of treatment
Each patient was managed by either the advanced wound care management
method or the currently used wound care management method for a period of
six weeks or until one of the following end points were reached:
~ the wound healed;
~ the patient withdrew;
~ an adverse event occurred in which treatment benefit was unacceptably
inferior to treatment risk.
151
The decision for a six-week treatment period was based on the treatment
period used in similar successful pressure sore studies undertaken by Kurring,
Roberts and Ouinlan (1994:1050), Colin, Kurring, Ouinlan and Yvon
(1996:444), Thomas, Banks, Bale, Fear-Price, Hagelstein, Harding, Orpin and
Thomas (1997:384) and Bale, Banks, Hageistein and Harding (1998:66) and
Price, Bale, Crook and Harding (2000:202). The decision was also based on
previous experience that pressure sores would either heal or make some
progress towards healing in six weeks.
6.6.4 Adverse event
The researcher took the following action in cases of an adverse event (see
conceptual definitions, Section 1.7): All patients experiencing an adverse
event were monitored until symptoms subsided or until there was a
satisfactory explanation for the changes observed. These observations were
forwarded to a suitably qualified clinician (the patient's primary caregiver
and/or attending physician) at the start of the event. Where the adverse event
placed the patient's wellbeing at risk, all experimental treatment was
discontinued, the patient withdrawn from the study and the case referred to
the qualified clinician. All findings were recorded under "adverse event(s)" on
page six (question 24) of the Weekly Wound Assessment Chart and page four
(question 14) of the Record of Dressing Changes and Products Used (see
Appendix 4) as well as in the study findings.
Additionally, if the adverse event occurred in the experimental group and was
thought to be a device-related adverse incident (see conceptual definition,
Section 1.7), Smith & Nephew™ were to be contacted immediately.
152
6.7 DATACOLLECTION
Data collection was facilitated by means of direct observation using four data
collection forms namely: an Initial Patient Information Chart, a Weekly Wound
Assessment Chart, a Record of Dressing Changes and an Assessment of
Dressing Acceptability. Additionally four evaluation methods were used to
assess the rate of wound healing namely:
~ standardised digital wound photography;
~ tracing of the wound edges;
~ measurements of the wound and its appearance as well as
~ descriptive field notes.
A digital camera (Sony Digital Mavica ™ MVC-FD7) was used to photograph
each wound weekly for six weeks. Direct observation and photography were
chosen as data collection methods for the following advantages that they
offered the study:
~ Both methods allowed the researcher to collect data in the natural setting.
This was of particular importance as the study was conducted in the
community.
~ Direct observation and photography facilitated analysis, validity checks,
and triangulation (Burns & Grove, 1993: 412).
Besides the data collected by means of direct observation and photography,
the presence of the researcher at the data collection phase of the study was
useful in providing additional information regarding the phenomenon. This
information was recorded on case record pages attached to each Weekly
Wound Assessment Chart and Record of Dressing Changes.
153
These field notes provided valuable insights into the phenomenon that could
not necessarily be obtained from the quantitative data collection methods.
6.7.1 The instruments
As mentioned, the data was collected using four data collection forms (see
Appendix 4), photography, tracing and measuring the wounds.
6.7.1.1 Data collection forms
These forms were developed from an extensive and exhaustive literature
review. In support of the review, domain experts were approached for
comments on the contents of the data collection forms. The four domain
experts included two wound care specialists form the School of Nursing of the
University of the Orange Free State and two bio-statisticians from the
Department of Biostatistics also at the University of the Orange Free State.
The wound care specialists were chosen for their qualifications and more than
20 years clinical experience in the field of wound care and nursing research.
The bio-statisticians were chosen for their unique qualifications in statistical
analysis as well as their vast experience in the field of clinical and health-
related research. Together these domain experts provided invaluable input
that contributed to the development and refinement of the data collection
forms.
Related items were grouped together to facilitate an easy, logical and practical
flow of data collection during the initial enrolment and at each subsequent
dressing change. This also ensured the elimination of any undue discomfort to
the patient during the data collection process.
154
The Initial Patient Information Chart, completed on initial enrolment, included
relevant baseline data such as gender, age, allergies, weight, length and
wound site. Content-related validity was supported by the assurance that the
key concepts namely, cost-effectiveness and acceptability as well as the
related constructs were included and adequately covered by questions on the
remaining three data collection forms. (The Weekly Wound Assessment
Chart, a Record of Dressing Changes and Products Used and an Assessment
of Dressing Acceptability). Table 6.1 (p.156) provides coverage of the
concepts in these data collection forms to assure that all the key areas of
concern were addressed.
6.7.1.2 Standardised digital wound photography
Standardised photography was chosen as an assessment method using a
Sony Mavica™ MVC-FD7 digital camera. Each wound was photographed on
entry, and thereafter every week, for six weeks. The weekly photographs of
each patient's wound can be viewed using the CD-ROM attached to the back
cover of this document.
A digital camera was chosen for the following advantages that it offered the
study:
This type of camera captures digital images that are directly transferred to a
computer disk. Therefore the cost and variables associated with conventional
film and film development processes were eliminated thus increasing the
reliability of this assessment method (see Chapter 4, Section 4.3.1.3 [c]). The
images taken were instantly visible to the researcher and the patient on the
camera's visual display screen. This feature enhanced patient motivation and
compliance with the treatment.
155
Furthermore, the images could instantaneously be transferred to a personal
computer without the need of a scanning device. Once the images were
transferred to a computer they could be stored, accessed at any time,
analysed and duplicated at no extra cost.
TABLE 6.1: Coverage of questions in data collection forms
Questions related to concepts
Concept Constructs
I U'.litt ...... '1i;rlli"""
.s: ••r-
Cost- • Cost of 16,17,18, 9,10,11,
effectiveness treatment 20 13
• Number of 6,7,19 3,4,12
dressing
changes
• Rate of healing: 8,9,10, 5,5. i, 5.2,
- Factors that 10.1,10.2, 6,7,9,10,
impede healing 11,12,14, 11
15,16,17,
18,21,22
Acceptability • Pain 13,13.1 8,8.1
• Comfort of 3.1,3.2
application and
removal
• Ease of 4.1,4.2
application and
removal
• Durability 6, t, 19 3,4,12 5
Form 1: Weekly Wound Assessment Chart (see Appendix 4)
Form 2: Record of Dressing Changes and Products Used (see Appendix 4)
Form 3: Assessment of Dressing Acceptability (see Appendix 4)
156
The photography was standardised by maintaining the same distance of 15
cm between the camera lens and the wound surface (see Section 4.3.1.3 [cl
.
vii) Camera settings such as focus and exposure were standardised and
maintained throughout the study (see Section 4.3.1.3 [cl i). The lighting was
standardised by the use of a portable Reflecta® Flectalux GLX 1006 halogen
lamp (see Section 4.3.1.3 [cl v). Additionally a disposable decimal ruler was
placed in the plane of focus of each photograph to facilitate measurements
made from the photographs. Comprehensive notes were made on each
occasion with regard to the patient's position and angle to the camera.
Previous photographs were kept available for reference at subsequent
sessions (see Section 4.3.1.3 [cl iv).
6.7.1.3 Tracing of the wound margins
Upon entry and thereafter at weekly intervals, the wound margins were traced
in the following manner. After the wound was cleansed, a Transparent OpSite
Flexigrid™ dressing was placed over the wound. The wound edges were then
carefully traced on the rigid flexigrid using a waterproof black felt-tipped pen.
The rigid flexigrid was then removed and attached to the patient's data
collection forms. The transparent Opsite™ film covering the wound, was left in
place to facilitate the following evaluation method namely measurements of
the wound.
6.7.1.4 Measurements of the wound
Immediately following the removal of .the rigid flexiqrid, a. decimal ruler was
placed over the transparent Opsite™ film covering the wound, and the
maximum length and width of the wound measured in millimeters.
157
Leaving the wound bed covered with the Opsite™ film whilst measuring,
eliminated direct contact of the ruler with the wound bed thereby avoiding the
possibility of cross-infection and/or further undue trauma to the delicate wound
surface area. As a further precautionary measure to avoid infection, the ruler
was cleansed with soap and water and disinfected with an alcohol swab in
between patients.
Surface area was calculated by assuming an elliptical shape:
a (area) = TTX r, x r2, where TT= 3.14
Figure 6.1: Area of an Ellipse
In the case of cavity wounds where it was possible to measure wound volume,
the following procedure as described by Flanagan (1997a:41), was followed.
After measuring the length and width of the wound, a 10ml. sterile syringe with
a 20 gauge needle was used to inject warm sterile physiologic saline through
the Opsite™ transparent film. Saline was injected until the cavity was filled,
whilst ensuring all air bubbles were removed. The wound volume (expressed
in millilitres) was calculated by deducting the remaining volume in the syringe
from 10 ml.
However, this method of determining wound volume could not be used in all
cavity wounds due to several practical reasons (Ter. Riet, Kessels &
Knipschild, 1998:261).
158
These included wounds located on or near joints or natural anatomical
curvatures where it was impossible to obtain a level surface area. Additionally,
in some cases the patient's general condition did not allow for them to be
positioned in an optimal position to perform this particular measurement
method.
In addition the appearance of the wound bed was assessed each week by
placing a metric grid with 5 rnrn" squares over the enlarged photographic
image of the wound on the computer screen. The black (necrotic), yellow
(slough), red (granulating) and pink (epithelializing) areas were then outlined
with a thin black felt tipped pen and the number of squares within each area
counted and expressed as a percentage of the total area (total number of
squares) of the traced wound surface. Consequently the wound appearance
could be measured with more accuracy and objectivity.
6.8 DATA ANALYSIS
The data analysis included a cost analysis and statistical analysis.
6.8.1 Cost analysis
The following was used to calculate the monetary cost" of wound treatment:
cost of wound care products and wound care tariffs.
4 All monetary costs referred to in this study were appropriate for the period
AugusUSeptember 2000.
159
6.8.1.1 Cost of wound care products
Data related to the type and amount of wound cleansers, topical applications
and dressing material used for each patient were analysed and the cost of
wound treatment per patient per group that completed the study, was
calculated.
The prices of all the products used in the experimental group were obtained
from suppliers of Smith & Nephew™ products in the Bloemfontein area.
However, the prices used in the cost analysis reflect the retail prices that
patients would have paid if they had bought the products through an
independent wound care practitioner.
In order to arrive at a reasonable cost for products used in the control group,
the researcher obtained the cost for each item from six different suppliers in
the Bloemfontein area and calculated an average cost per item. Two
independent wound care practitioners verified the prices and cost calculations
(Smart, 2000; Blom, 2000). See Appendix 9 for price lists and cost analysis.
Saline as wound cleanser, was excluded from the cost analysis in both groups
since saline can be made by patients and their caregivers in the community
setting at a minimal cost (see Section 4.5.2.1rh]). However, for the sake of
convenience and practicality pre-packed saline containers (Adcock Ingram's
30 ml Sab-Saline™ ampoules) were used in the experimental group. Similarly
the cost of a gentle soap (see Section 6.6.1) to clean the peri-wound area in
both groups was excluded in the cost calculations since most patients already
used this or a similar item.
160
6.8.1.2 Wound care tariffs
The wound care tariffs as published by the Board of Health Care Funders
(2000), were used in the calculation of the treatment cost. The severity (stage)
of the pressure sore determined the treatment tariff. The tariffs list is included
in Appendix 9.
6.8.2 Cost-effectiveness
Using the same methodology as proposed by Harding, Bale, Banks and Orpin
(1994:9) of the Wound Healing Research Unit, Cardiff, cost-effectiveness was
expressed by dividing the number of patients that healed into the total cost of
treating that particular group. This indicated the cost of healing per patient
healed.
6.8.3 Statistical analysis
Data was analysed by a statistician from the Department of Biostatistics of the
University of the Orange Free State, using S.A.S. software. Demographic and
baseline information was summarized by group. Numeric variables were
summarized by means and standard deviations, or percentiles if the
distributions were skew. Categorical variables were summarized by
frequencies and percentages. Changes between baseline and consecutive
treatment week information were summarized per group by means and
standard deviations, percentiles or percentages, as appropriate for the
difference between the groups, with 95% confidence intervals. The
percentage of dropouts, withdrawals and adverse events were compared
between the two groups using 95% confidence intervals for differences in
percentages.
In support of the use of confidence intervals the following was considered.
Since no single study determines the scientific opinion on a subject, it is
incumbent upon the researcher to provide a' more complete analysis of the
study results.
161
Therefore methodologists in particular recommend that clinical researchers
routinely report confidence intervals rather than probability (P) values (Bailar &
Mosteller, 1992:186; Armitage & Berry, 1994: 98). Gardner and Altman (1989:
13) advocate the use of confidence intervals by stating the following: "The
confidence interval thus provides a range of possibilities for the population
value, rather than an arbitrary dichotomy based solely on statistical
significance. There is a close link between the use of a confidence interval
and a two-sided hypothesis test. If the confidence interval is calculated then
the result of the hypothesis test can be inferred at an associated level of
statistical significance."
6.9 VALIDiTY AND RELIABILITY
To increase the validity and reliability of the study, several approaches and
techniques were applied, namely: assuring content-related validity evidence;
addressing mono-operation bias; consistent use of instrument; randomization;
inclusion of homogenous patients, conducting of a pilot study and monitoring.
6.9.1 Assuring content-related validity evidence
The researcher assured the content-related validity evidence in the following
manner. The preliminary data collection forms were forWarded to four domain
experts for comment regarding the appropriateness, accuracy and
representativeness of items on the forms (see Section 6.7.1.1). Once these
comments were returned, appropriate changes to refine the forms were made.
They included grouping of items, coding block changes and refinement of item
seven on the Record of Dressing Changes and item 12 on the Weekly Wound
Assessment Chart. These refinements were important as they assisted in the
early recognition of wound infection, which was an exclusion criterion.
162
6.9.2 Addressing mono-operation bias
Mono-operation bias, as described by Burns and ·Grove (1993:269), to assess
wound healing, was addressed by the use of multiple evaluation methods (as
described in Section 6.7), thereby improving the construct validity. The
evaluation methods included the following:
o Standardised wound photography using the same automatic digital camera
(Sony Digital Mavica™ MVC-FD7) and operated consistently by the same
individual thereby limiting user errors (see Section 6.7.1.2);
o Tracing of the wound edges using a standard transparent grid (see Section
6.7.1.3);
o Accurate measurements of· the length, width and where applicable the
volume of the wound, by means of the consistent use of a decimal
measurement tool (see Section 6.7.1.4);
o Objective assessment of the appearance of the wound bed (see Section
6.7.4.1);
o Narrative descriptive field notes of the wound appearance made by the
researcher.
6.9.3 Consistent use of instrument
Reliability of the instrument was improved through consistent use of it
throughout the data collection process. This was facilitated by the use of only
one data collector, a practice known to bypass the bias and inconsistency
caused by multiple data collectors as well as problems associated with
interrater reliability.
163
6.9.4 Randomization
Random assignment to experimental and control groups was used as a
design strategy to control extraneous variables such as unrelieved pressure,
incontinence, age, level of health, nutritional and functional status. Lack of
equivalence between the experimental and control groups was also controlled
by random assignment of patients to groups. .
6.9.5 Inclusion of homogeneous patients
Patients were homogeneous in terms of three extraneous variables namely
the presence of a clinically uninfected Stage 2, 3 or 4 pressure sore, aged 18
years or older and living in the community within the boundaries of the
Municipal area of Bloemfontein.
6.9.6 Pilot study
Two patients, who complied with the inclusion and exclusion criteria as
described in Sections 6.4.2 and 6.4.3, were selected to constitute a pilot
study.
One was allocated to the experimental group and the other to the control
group as described in Sections 6.6.1 and 6.6.2. The patients were randomly
allocated to the respective treatment methods. The pilot study commenced on
19 May 1999 and was concluded two weeks later on 2 June 1999. The pilot
study provided the researcher with the opportunity to test and improve the
data collection forms with regard to how long they took to complete, the order
and grouping of items. It also provided the researcher with the opportunity to
become familiar with the digital camera and standardising the photographic
technique in terms of lighting, background,' distance and angle, thereby
facilitating and maintaining accuracy and consistency during data collection.
164
6.9.7 Monitoring
The study and treatment methods were continuously monitored by Smith &
Nephew's official study monitor as well as the two study leaders who regularly
accompanied the researcher on visits to patients, thereby improving the
validity and reliability of the study.
6.10 ETHICAL CONSIDERATIONS
The three main ethical considerations in this study refer to the right to self-
determination, confidentiality and protection from harm.
6.10.1 The right to self determination
Patients were asked to partake voluntarily in this study (see Appendix 1).
Patients were only enrolled into the study with written informed consent,
provided by themselves or their legal guardians, and where possible in
collaboration with their attending physician(s).
All participants were asked to sign a consent form, which contained a detailed
description of the trial procedures and methods. Consent forms were available
in Afrikaans, English, and South-Sotho (see Appendix 5). In addition patients
had the right to withdraw from the study at any time without penalty.
6.10.2 Confidentiality
All patient names were kept confidential. The study number allocated to them
during the study identified patients throughout the evaluation and
documentation. Where any photograph taken of a patient's wound in any way
revealed the patient's face, this area was blacked out to protect the patient's
identity. The patients were told that all study findings would be stored on
computer and handled in the strictest confidence. The signed informed
consent forms remained with the researcher. The researcher also agreed to
keep the forms for 15 years and will allow them to be inspected on request.
165
6.10.3 Protection from harm
All patients were carefully monitored and where any adverse event occurred,
which, in the opinion of the researcher, was a result of the- trial management
method, the patients concerned were discontinued and managed
appropriately as discussed in Section 6.6.4).
6.10.4 Declaration of Helsinki
The study was performed in accordance with the guidelines of the Declaration
of Helsinki (1964) as revised in Tokyo in 1975, Venice in 1983, Hong Kong in
1989 and Somerset West, South Africa in 1996 (see Appendix 6 for a copy of
the declaration).
6.10.5 Approval of protocol
Before the start of the study, the researcher submitted the study protocol and
advertisement to the Ethics Committee, Faculty of Health Sciences, University
of the Orange Free State, Bloemfontein. The study was initiated after the
protocol and format of the newspaper advertisement were approved and a
copy of the ethics approval received in which the protocol was mentioned by
name and number (see Appendix 10 for a copy of the Ethics Committee
approval letter).
6.11 TIMING
The study commenced on 4 June 1999 after the Ethics Committee approval
was obtained. It continued uninterruptedly for 12 months until 18 June 2000,
when the required sample size, as mentioned in Section 6.5, was attained.
166
6.12 CONCLUSiON
The design and methodology of this study were chosen through careful
consideration of the phenomenon under investigation. The unique needs were
then matched to the most appropriate research design and methodology.
167
CHAPTER §EVEN
lReslLO~1ts and d10SClLOSSOOO1l
168
7.1 Introduction
The preceding chapter provided a detailed exposition of the research
methodology followed in this study. In this chapter the results of the data
analysis will be interpreted and discussed.
7.2 Base-line data
Sixty patients were screened for inclusion in the study, of whom 58 patients
(N=58) were considered suitable for entry. Upon entrance 28 patients were
randomly allocated to the experimental group (ne=28), as discussed in Section
6.5, and 30 patients to the control group (nc=30). On entry base-line data was
acquired by means of two forms (See· Appendix 4). The Initial Patient
Information Chart was used to gather demographic data and all the relevant
assessment data with regard to the pressure sore was recorded on the
Weekly Wound Assessment Chart.
7.2.1 Initial Patient Information Chart
The base-line demographic data of both groups acquired on entry using the
Initial Patient Information Chart, were the following: gender, age, allergies,
weight, height (body mass index) and wound site. This data is provided in
Table 7.1 and discussed below.
169
TABLE 7.1: Base-line demographic data
Demographic data Experimental group Control group
(ne=28) (nc=30)
7 (25%) 16 (53%)
21 (75%) 14 (47%)
Minimum 19 yrs 24 yrs
Median 76,5 yrs 78 yrs
Maximum 89 yrs 97 yrs
5 C.1. [-10; 1]
None 27 (96,4%) 28 (93,3%)
Morphine 1 (3,6%) o
Penicillin o 1 (3,3%)
Bee sting o 1 (3,3%)
Minimum 17 13
Median 22 21
Maximum 27 28
C.1. [-1,63; 2,07]
Table 7. 1 continues ...
5 C.1. indicates 95% confidence intervals for the median difference between the experimental
and control groups. Values in brackets refer to those values of the respective groups: [control;
experimental]. When the inte.......,aI includes zero it is an indication that there may be no
difference, in which case the probability (P) value will be larger than 0,05 and the null
hypothesis will therefore not be rejected.
6 The sum of individual percentages may at tirnes not total 100% due to rounding off errors.
170
TABLE 7.1: Base-line demographic data continued •..
Experimental group Control group
Demographic data
(ne=28) (nc=30)
(n=7) (n=16)
underweight <20 2 (28,6%) 8 (50%)
normal weight 2:20 and :525 5 (71,4%) 7 (43,8%)
overweight >25 0 1 (6,2%)
(n=21)
underweight <19 4 (19,1%) 2 (14,3%)
normal weight 2:19 and :524 9 (42,9%) 8 (57,1%)
overweight >24 8 (38%) 4 (28,6%)
underweight 6 (21,4%) 10 (33,3%)
normal weight 14 (50%) 15 (50%)
overweight 8 (28,5%) 5 (16,6%)
(using the BMI as
reference)
Sacrum 11 (39%) 15 (50%)
Trochanter 6 (21,4%) 6 (20%)
Malleolus 3 (10,7%) 0
Iliac crest 2 (7,1%) 2 (6,7%)
Ischium 2 (7,1%) 1 (3,3%)
Heel 2 (7,1%) 3 (10%)
Wrist 1 (3,6%) 0
lat. side of foot 1 (3,6%) 0
Elbow 0 2 (6,7%)
Scapula 0 1 (3,3%)
171
7.2.1.1 Gender
From Table 7.1 it can be seen that the patients in the experimental group
were predominantly females (75%) as opposed to the control group where
gender distribution was more balanced. However, the disparate gender
distribution between the two groups was of no clinical importance.
7.2.1.2 Age
The median age of patients in the experimental group was 76,5 years and that
of the control group 78 years. This finding confirms the association of the
aging process with the incidence of pressure sores as presented in the
literature (Banks, 1997:507; Scott, 1998:78). The 95% confidence interval [-
10; 1] suggests that patients in the control group tended to be older. Similarly
this tendency was not significant and of no clinical importance.
7.2.1.3 Allergies
As far as allergies were concerned no patient in either group had an allergy
that could have had any undue influence on the wound treatment and/or
outcome.
7.2.1.4 Body mass index (weight distribution)
There was no significant difference [-1,63; 2,07] in weight distribution between
the two groups.
172
7.2.1.5 Wound site
As Table 7.1 indicates, the majority of pressure sores in both the experimental
group (70 %) and control group (60,4%) were located an the sacrum ar
trochanters, both common at risk sites for pressure sore development
according to Lueckenotte (1995:791). However, the site with the highest
frequency of ulceration was the sacrum.
7.2.2 Weekly wound assessment chart - week zero
The baseline data with regard to assessment of the pressure sores (wounds)
for both groups were acquired during week zero (on entry) by means of the
Weekly Wound Assessment Charl. The initial wound assessment data
included the pressure sore risk assessment, vround duration since onset,
dimensions, pressure sore stage, level of exudate, appearance of the wound
bed, surrounding skinlwound margin, pain, factors that may delay wound
healing and medications used. This data is compared in Table 7.2 and
discussed below.
TABLE 7.2: Base-line pressure sore (wound) assessment data
Assessment data Experimental group Control group
(ne=28) (nc=30)
- - , ..... ,;,r. 11l~1~1j .I;.;;U~ t.... ~II~TI- , I.."'" tt't::'ll1!1-'1- ,
Number of patients with a 26 (92,9%) 26 (86,7%)
Braden score of 18 or less
I- ,n.Imr.1ffilllw' --I~
Minimum 1 week 1 week
Median 2 weeks 2 weeks
Maximum 72 weeks 520 weeks
C.1. [-1; 1]
-
Table 7.2 contmues ...
173
TABLE 7.2: Base-line pressure sore (wound) assessment data
continued •••
Assessment data Experimental group Control group(ne=28) (nc=30)
Length
minimum
median 3mm 5mm
maximum 22,5 mm 18,5 mm
C.1. [-7; 10] 85 mm 145 mm
Width
minimum
median 4mm 4mm
maximum 14 mm 11 mm
C.1. [-4; 6] 73mm 70 mm
Area
maximum 2
median 5694 mm
174 mm"
23 mm2
Stage 2 21 (75%) 23 (76,6%)
Stage 3 5 (17,8%) 4 (13,3%)
Stage 4 2 (7,1%) 3 (10%)
High 3 (10,7%) 2 (6,7%)
Medium 5 (17,9%) 4 (13,3%)
Low 20 (71,4%) 24 (80%)
Bloody 0 0
Serous 22 (78,6%) 25 (83,3%)
Serosanguineous 3 (10,7%) 3 (10%)
Combination/other 3 (10,7%) 2 - .....(6,7%)
Table 7.2 continues ...
174
TABLE 7.2: Base-line pressure sore (wound) assessment data
continued ...
Assessment data Experimental group Control group
(ne=28) (nc=30)
Necrotic/ black tissue 18% 7,6%
Col. [0; 10]
Slough/ yellow tissue 16,9% 25,6%
Col. [-20; 5]
Granulating/ red tissue 46,7% 48,9%
Col. [-20; 15]
Epitheliating/ pink tissue 18,2% 18,8%
Col. [-10; 10]
Intact 24 (85,7%) 25 (83,3%)
Erythema 5 (17,9%) 8 (26,7%)
Indurated 0 0
Macerated 2 (7,1%) 2 (6,7%)
Oedematous 2 (7,1%) 1 (3,3%)
localised heat 0 0
Fragile 14 (50%) 13 (43,3%)
Dry-scaling 0 0
¥r~~
Table 702 continues 000
175
TABLE 7.2: Base-line pressure sore (wound) assessment data
continued •.•
Assessment data Experimental group Control group
(ne=28) (nc=30)
No pain 24 (85,7%) 28 (93,3%)
At dressing change 3 (10,7%) o
Intermittent o 1 (3,3%)
Persistent 1 (3,6%) 1 (3,3%)
@. 24 (85,7%) 28 (93,3%)
CI o o,D
CID 2 (7,1%) o,
CID 2 (7,1%) 1 (3,3%)
•
CID o 1 (3,3%)
® o o•
Poor nutrition 19 (67,9%) 20 (66,7%)
Impaired circulation 18 (64,3%) 23 (76,7%)
Impaired sensation 7 (25%) 8 (26,7%)
Foreign bodies 0 0
Dehydration 0 1 (3,3%)
Non-compliance 1 (3,6%) 2 (6,7%)
Smoking 2 (7,1%) 2 (6,7%)
Table 7.2 continues ... . ""'" -
176
TABLE 7.2: Base-line pressure sore (wound) assessment data
continued ••.
Assessment data Experimental group Control group
(ne=28) (nc=30)
Underlying disease 7 (25%) 14 (46,7%)
Pharmacological agents 11 (39,3%) 11 (36,7%)
Impaired mobility 25 (89,3%) 24 (80%)
Complementary medicines 0 0
Anaemia 0 2 (6,7%)
Mechanical forces 26 (92,9%) 30 (100%)
Systemic infection 0 2 (6,7%)
None 8 (28,6%) 8 (26,7%)
NSAIDS 5 (17,9%) 4 (13,3%)
Chemotherapy 0 1 (3,3%)
Beta-blockers 0 1 (3,3%)
Anticoagulants 3 (10,7%) 4 (13,3%)
Phenotoin 2 (7,1%) 1 (3,3%)
Radiation 0 0
Analgesia 3 (10,7%) 3 (10%)
Sedatives 4 (14,3%) 2 (6,7%)
Diuretics 3 (10,7%) 6 (20%)
Antibiotics 1 (3,6%) 2 (6,7%)
Laxatives 0 1 (3,3%)
Steroids 0 2 (6,7%)
177
7.2.2.1 Risk assessment score
A Braden Scale score of 18 or less, indicating a patient at risk for pressure
sore development was given to 92,9% patients in the experimental group and
86,7% patients in the control group. Since all patients had pressure sores,
these percentages reflect the high sensitivity of the Braden Scale in predicting
pressure sore development. These results confirm the research findings of
Pang and Wang (1998:148) and support the use of the Braden Scale in this
study.
7.2.2.2 Wound duration
The median wound duration in both groups was two weeks, again indicating
no significant difference between the two groups on entry as far as this
particular variable was concerned.
7.2.2.3 Wound dimensions
The median surface area of wounds in the experimental group was 250 mm 2
and those in the control group 222 mm 2 with the 95% confidence interval [-
111; 175] indicating no significant statistical difference with regard to wound
dimensions of patients upon entry.
7.2.2.4 Pressure sore stage
Most patients, (21 [75%] in the experimental group and 23 [76,6%] in the
control group) were assessed as having stage two pressure sores and the
remainder classified as stages three and four. These results indicate an even
distribution with regard to pressure sore staging.
178
7.2.2.5 Wound exudate, appearance and margins
Most patients in both groups had a low level of wound exudate. Similarly the
majority of patients [22 (78,6%) in the experimental group and 25 (83,3%) in
the control group] had the same type of wound exudate (serous). It is also
evident from the confidence intervals listed in Table 7.2 above, that there was
no significant difference between groups in the assessment of the appearance
of the wound bed. Assessment of the wound margins on entry revealed that
24 (85,7%) patients in the experimental group and 25 (83,3%) patients in the
control group had intact wound margins.
7.2.2.6 Pain
Three patients allocated to the experimental group (10,7%) experienced pain
at dressing change on entry. It should be noted, however, that the reported
pain was associated with the removal of the dressings that were in place on
recruitment and not the experimental treatment that was initiated.
7.2.2.7 Factors that may delay wound healing
Multiple factors that could delay healing were identified in all patients. The two
factors that occurred with the highest frequency in both groups were
mechanical forces and impaired mobility. Additionally there was a high
incidence of impaired circulation and poor nutrition in both groups. These
results are consistent with those factors identified from the literature that not
only impair the wound healing process, but contribute to the development and
maintenance of pressure sores (Flanagan, 1997b:30).
179
7.2.2.8 Medications used
The two groups were also similar as far as medication use was concerned.
Statistical analysis (using 95% confidence intervals) of the base-line data
presented in Tables 7.1 and 7.2, revealed no significant differences between
the two groups on entry. This important fact confirms that the process of
randomization by stage, as described in the methodology, succeeded in
producing two equivalent groups of patients that were homogenous in terms
of demographic and prognostic factors and thus comparable - a vital
prerequisite for experimental research. See Section 6.5.
7.3 Progression of the study
In the section below results of the following will be presented: weekly
comparison of groups; comparison of each week with baseline data;
withdrawals; reasons for withdrawals; healers and non-healers.
7.3.1 Weekly comparison of groups
The following section will indicate how the patients in both groups that
remained in the study compared with each other per week in terms of the
following variables: Braden risk assessment score; wound dimensions (area)
and wound appearance (percentage necrotic, slough, granulation and
epithelial tissue).
180
7.3.1.1 Comparison of Braden scores
The 95% confidence intervals in the Table below indicate that there were no
significant differences in the weekly Braden scores of patients that remained
in the study. Therefore the patients remained comparable in terms of the risk
factors assessed by the Braden scale (See Section 4.2.6).
TABLE 7.3: Comparison of Braden risk assessment scores
95%
Experimentalgroup Confidence Control group
interval
Week one N=26 N=26
Minimum 7 7
Median 12 11.5
Maximum 22 [-2; 2] 20
Week two N=20 N=22
Minimum 7 7
Median 11.5 11.5
Maximum 18 [-2; 2] 19
Week three N=17 N=17
Minimum 8 7
Median 12 12
Maximum 22 [-2; 4] 19
Week four N=14 N=11
Minimum 9 7
Median 12 11
Maximum 22 [-1; 5] 19
Week five N=12 N=11
Minimum 9 7
Median 12.5 11
Maximum 22 [-1; 6] 19
Week six N=11 N=10
Minimum 9 7
Median 14 10.5
Maximum 22 [0; 6] 19
181
7.3.1.2 Comparison of wound dimensions
There were no significant differences in the weekly measurements of wound
area between the two groups as can be noted by the confidence intervals in
Table 7.4.
TABLE 7.4: Comparison of wound dimensions (area)
95%
Experimentalgroup Confidence Control group
interval
Week one N=26 N=26
Minimum 9 mm" 23 mm2
Median 164 mm2 174 mm2
Maximum 4873 mm2 [-84; 126] 5694 rnrrr'
Week two N=20 N=22
Minimum 9 mm" 23 mm"
Median 209 mm2 191 mm2
Maximum 4873 mm2 [-119; 215] 5694 mm2
Week three N=17 N=17
Minimum 23 mm" 37 mm'
Median 214 mm2 188 mm2
Maximum 4873 mm2 [-110; 283] 5694 mm2
Week four N=14 N=11
Minimum 24 mm2 47 mm"
Median 296 mrn" 242 rnrn"
Maximum 4873 mm" [-230; 452] 5694 mm"
Week five N=12 N=11
Minimum 24 mm2 47 mm2
Median 209 mm2 242 mm2
Maximum 4873 mm2 [-268; 371] 5694 mm2
Week six N=11 N=10
Minimum 24 mm2 47 mm2
Median 377 mm2 225 mm"
Maximum 4873 mm" [-605; 538] 5694 mm2
182
7.3.1.3 Comparison of wound appearance
The weekly measurements of the wound appearance (measured in terms of
the percentage of necrotic. slough. granulating and epttheHalatingtissue) of
patients who remained in the study are compared in Table 7.5 below. Once
again no significant differences were found between groups with regard to
wound appearance as indicated by the 95% confidence intervafs. Therefore
the patients that remained in the study were comparable with regard to this
variable.
TABLE 7.5: Comparison of wound appearance
95%
Experimentalgroup Confidence Control group
interval
Weekone N=26 N=26
% Necrotic tissue
Minimum 0% 0%
Median 0% 0%
Maximum 100% [0; 0] 100%
% Slough tissue
Minimum 0% 0%
Median 7.5% 10%
Maximum 90% [-25; 5] 95%
% Granulation issue
Minimum 0% 0%
Median 45% 45%
Maximum 100% [-20; 20] 100%
% Epithelialating tissue
Minimum 0% 0%
Median 10% 15%
Maximum 60% [-10; 5] 85%
Weektwo N=20 N=22
% Necrotic tissue
Minimum 0% 0%
Median 0% 0%
Maximum 100% [0; 20] 100%
Table 7.5 continues ...
183
TABLE 7.5: Comparison of wound appearance continued •.•
95%
Experimental group Confidence Control group
interval
Week two continued.. N=20 N=22
% Slough tissue
Minimum 0% 0%
Median 10% 10%
Maximum 70% [-20; 5] 95%
% Granulation tissue
Minimum 0% 0%
Median 40% 45%
Maximum 100% [-25; 15] 100%
% Epithelialating tissue
Minimum 0% 0%
Median 12.5% 17.5%
Maximum 60% [-10; 10] 85%
Week three N=17 N=17
% Necrotic tissue
Minimum 0% 0%
Median 0% 0%
Maximum 100% [0; 20] 100%
% Slough tissue
Minimum 0% 0%
Median 10% 30%
Maximum 90% [-25; 10] 80%
% Granulation tissue
Minimum 0% 0%
Median 40% 45%
Maximum 90% [-35; 10] 100%
% Epithelialating tissue
Minimum 0% 0%
Median 15% 15%
Maximum 60% [-10; 10] 50%
Week four N=14 N=11
% Necrotic tissue
Minimum 0% 0%
Median 5% 0%
Maximum 100% [0; 20] 100%
% Slough tissue
Minimum 0% 0%
Median 15% 10%
Maximum 90% [-10; 20] 70%
Table 7.5 continues ...
184
TABlE 7.5: Comparison of wound appearance continued ...
95%
Experimentalgroup Confidence Control group
interval
Weekfour continued.. N=14 N=11
% Granulation tissue
Minimum 0% 0%
Median 20% 50%
Maximum 90% [-50; 5] 100%
% Epithelialating tissue
Minimum 0% 0%
Median 10% 10%
Maximum 60% [-15; 10] 50%
Weekfive N=12 N=11
% Necrotic tissue
Minimum 0% 0%
Median 5% 0%
Maximum 100% [0; 20] 100%
% Slough tissue
Minimum 0% 0%
Median 15% 10%
Maximum 90% [-10; 30] 70%
% Granulation tissue
Minimum 0% 0%
Median 17.5% 50%
Maximum 90% [-60; 0] 100%
% Epithelialating tissue
Minimum 0% 0%
Median 10% 10%
Maximum 60% [-15; 10] 50%
Weeksix N=11 N=10
% Necrotic tissue
Minimum 0% 0%
Median 0% 0%
Maximum 100% [0; 20] 100%
% Slough tissue
Minimum 0% 0%
Median 20% 10%
Maximum 90% [-10; 35] 70%
% Granulation tissue
Minimum 0% 0%
Median 20% 47.5%
Maximum 90% [-50; 20] 90%
% Epithellalstlng tissue
Minimum 0% 0%
Median 10% 12.5%
Maximum 60% [-20; 10] 50%
185
From the above it is evident that despite withdrawals the groups remained
comparable throughout the study period
7.3.2 Comparison of each week with baseline data
This section will show the results (95% confidence intervals) of the differences
between each successive week and baseline (i.e. week 1minus week 0; week
2 minus week 0 etc.), as well as the difference between groups in terms of the
following variables: Braden risk assessment score; wound dimensions (area)
and wound appearance (percentage necrotic, slough, granulation and
epithelial tissue).
TABLE 7.6: Differences in variables between groups per week
Week 1-0 [0; DJ
Week 2-0 [0; DJ
Week 3-0 [-5; 2J
Week 4-0 [0; DJ
Week 5-0 [0; DJ
Week 6-0 [0; DJ
Wound area
Week 1-0 [-89; 31J
Week 2-0 [-162; 60]
Week 3-0 [-210; 16]
Week 4-0 [-264; 148]
Week 5-0 [-185; 234]
Week 6-0 [-477; 234]
Wound appearance
% Necrotic tissue
Week 1-0 [0; 0]
Week 2-0 [0; 0]
Week 3-0 [-10; 0]
Week4-0 [-20; 0]
Week 5-0 [-75; 0]
Week 6-0 [-75; 0]
Table 7.6 continues ...
186
TABLE 1.6: Differences in v21rialblUesbetweetnl grolUlps per ~®®It
c«mto tnllUl®<.d..I
Variable/week 95% Confidence interval
~ J '."; , , t', _i Il;:'. ";', -,
% Slough tissue
Week 1-0 [0; 5]
Week 2-0 [-5; 10]
Week 3-0 [-10;20]
Week 4-0 [-15; 5]
Week 5-0 [-15; 10]
Week 6-0 [-20; 10]
% Granulation tissue
Week 1-0 [-5; 5]
Week 2-0 [-10; 5]
Week 3-0 [-15;20]
Week4-0 [-15;25]
Week 5-0 [-15; 35]
Week 6-0 [-20; 35]
% Epithelia/sting tissue
Week 1-0 [-5; 10]
Week 2-0 [-5; 20]
Week 3-0 [-15; 25]
Week 4-0 [-10;40]
Week 5-0 [-10; 50]
Week 6-0 [-15; 80]
From the confidence intervals in the Table above it can be seen that êllthough
there '\I'v"ereno significant differences between the groups with regard to the
indicated variables there were discernable trends in the appearance of the
wounds.
187
The difference in the percentage of necrotic tissue in the control group
between week zero and week one, compared with the difference in the
experimental group was similar [0; 0]. However, the difference between week
zero and week six, compared with the difference in the experimental group
was [-75; 0]. This confidence interval indicates a higher value for the control
group thereby suggesting that the wounds in this group had more necrotic
tissue than the experimental group when comparing week six with week zero.
In addition, the confidence intervals indicating the differences in percentages
of epithelialating tissue of wounds in the experimental group in relation to the
control group, increased from week zero to week six [-15; 80]. This finding
suggests that wounds in the experimental group progressed more rapidly
towards healing than wounds in the control group.
The following section will provide an overview of the progression of the study
during the six-week treatment period with regard to patients who withdrew,
whose pressure sores were healed and those in whom healing was not
achieved. For the sake of discussion these groups will be referred to as the
withdrawals, healers and non-healers.
7.3.3Withdrawals
Fifty-eight patients (N=58) were enrolled in the study in week zero. However,
during the course of the six-week period a total of 17 (29,3%) patients were
withdrawn as they died, moved from the geographical area, developed a
wound infection or were hospitalized. Table 7.7 below indicates the frequency
and cumulative frequency (Cf.) of withdrawals in both treatment groups by
week. Patients whose pressure sores healed during the study period are also
indicated.
188
TABLE 7.7: Withdrawals and healing by week
1 1
moved 1 3
healed 0 0
infected 0 0
hospitalized 0 0
Week two
died o (1) 1 (2)
moved o (1) o (3)
healed 5 (5) 3 (3)
infected o o
hospitalized o o
missed visit 1 (1)
Week three
died 1 (2) 3 (5)
moved o (1) o (3)
healed 2 (7) 1 (4)
infected 1 (1) 1 (1)
hospitalized o o
Week four
died (2) (7)
moved (1) (3)
healed (10) (7)
infected (1) (1)
1 (3) 0 (7)
0 (1) 0 (3)
0 (10) 0 (7)
0 (1) 0 (1)
0 0 (1)
1
died
moved o (1)
healed 3 (15)
infected o (1)
hospitalized o
non-healers 8
189
Table 7.8 below provides a summary of the population status at the end of the
six-week study period with regard 10 the frequency and percentage of
withdrawals, healers and non-heaters for comparison (as can be seen in the
graphic representation withrn the Table).
TABLE 7.8: Population (N=58) status at the end of the study period
Experimental group Control group
(ne=28) (nc=30)
Status Frequency % Frequency %
Healed 15 (53,6%) 9 (30%)
Non-healers 8 (28,6%) 9 (30%)
Died 3 (10,7%) 7 (23,3%)
Moved 1 (3,6%) 3 (10%)
Infected 1 (3,6%) 1 (3,3%)
Hospitalized 0 (0%) 1 (3,3%)
Experimental group (ne=28) Control group (nc=30)
I] healed
• non-healers
IIIdied
IIImoved
Dlnfected
• hospitalized
7.3.4 Reasons for withdrawals
A discussion of the reasons for withdrawals follows below.
7.3.4.1 Death
Table 7.8 indicates that more patients in the control group died than in the
experimental group.
190
However, none of the deaths in either group were in any way related to the
patients' pressure sores or their particular wound treatment.
7.3.4.2 Moved from the geographical area
One patient (3,6%) in the experimental group and three patients (10%) in the
control group moved from the geographical area and had to be withdrawn.
7.3.4.3 Infection
Wound infections occurred in the wounds of two patients, one in each group.
Notably both patients were assessed as non-compliant with regard to their
wound treatment, neither were their living environment hygienic or conducive
to wound healing.
7.3.4.4 Hospitalized
One patient in the control group was hospitalized. The reason for
hospitalization was not related in any way to the patient's wound or treatment
method.
7.3.5 Healers and non-healers
Table 7.8 indicates that the total number of patients who completed the
study, that is, the healers and non-healers, was 41. This represents 70,6% of
the total study population (N=58).
191
7.3.5.1 Healers
The wounds of a significant number of patients 15 (53,6%) in the experimental
group were healed as opposed to only 9 (30%) in the control group. Notably
all the wounds that healed in both groups were classified upon entry as stage
two pressure sores.
7.3.5.2 Non-healers
An almost equal number of patients in both groups [8 (28,6%) in the
experimental group and 9 (30%)] in the control group - remained for the entire
study duration but did not achieve healing.
In the following section the results of the cost analysis related to the treatment
of patients that completed the study (N=41), will be discussed.
7.4 Cost analysis
A comparative analysis of the treatment cost of the experimental group with
that of the control group was performed (See Appendix 9). The proceeding
sections will examine the cost analysis of three sub-groups, namely all
patients who completed the study (N=41), those whose wounds healed
(N=24) and the non-healers (N=17).
7.4.1 Cost analysis of patients that completed the study
The cost of treating each patient that completed the study (healers and non-
healers) was calculated as described in Section 6.8.1. A determining factor in
the cost calculation was the number or frequency of dressing changes.
192
The frequency of dressing changes of those that completed the study is
indicated in the Table below.
TABLE 7.9: Frequency of dressing changes of completers
Experimental group Control group
(ne=23) lnc=18)
Minimum 2 2
Median 10 18
Maximum 40 47
95% confidence interval: [-16; 0] I
From the median values and 95% confidence intervals in Table 7.9 it is clear
that the control group had a higher frequency of dressing changes than the
experimental group. Subsequently the total treatment costs of the two groups
(ne=23 and nc=18)were compared. See Table 7.10 below.
TABLE 7.10: Comparison of the total treatment cost for all the patients
(N=41) that completed i.e. healers and non-healers
Experimental group Control group
(ne=23) (nc=181
Minimum R 58.28 R 82.58
Median R 677.39 R 955.96
Maximum R 4373.49 R 2754.02
95% confidence interval: [-789.75; 159.12]
193
Despite the fact that there were no significant differences between the two
groups as far as cost is concerned, it is evident from the 95% confidence
interval [-789.75; 159.12] in Table 7.10, that there was a tendency for the
control group to have higher values indicating that the control treatment
tended to be more expensive than the experimental treatment.
7.4.2 Cost analysis of patients who were healed
The number of dressing changes in patients who were healed is provided in
Table7.11.
TABLE 7.11: Frequency of dressing changes of patients who were
healed
Experimental group Control group
(ne=15) (nc=9)
, Minimum 2 2
Median 7 11 I
Maximum 12 24
95% confidence interval: [-12; 1]
The median values and 95% confidence intervals in Table 7.11 indicate a
tendency for patients in the experimental group who were healed, to have
fewer dressing changes than those in the control group.
A comparison of the cost analysis of the treatment for patients in both groups
who were healed (N=24) is provided in Table 7.12.
194
TABLE 7.12: Cost to achieve healing
Experimental group Control group
(ne=1S) (nc=91
Minimum R 58.28 R 82.58 !
I Median R 379.52 R 773.25
i
Maximum R 1 102.55 R 1 177.96
I
95% confidence interval: [-508,28; 159.12]
Again there were no significant differences between the two groups. However
the values of the 95% confidence interval [-508,28; 159.12] in Table 7.12
suggest that the cost to achieve healing in the control group was higher than
in the experimental group. Conversely, the cost to achieve healing in the
experimental group, using advanced wound care methods, tended to be less
expensive.
7.4.3 Cost analysis of non-healers
A total of 17 patients who completed the study were classified as non-healers
at the end of the study period. A comparison of the frequency of dressing
changes between patients in this sub-group is presented in Table 7.13.
TABLE 7.13: Frequency of dressing changes of non-healers
Experimental group Control group
(ne=8) (nc=9)
Minimum 11 7
Median 19.5 35
Maximum 40 47 :
95% confidence interval: [-23; 4]
195
The data presented in Table 7.13 also suggest a tendency that non-healers in
the control group required more frequent dressing changes than the non-
healers in the experimental group. A cost comparison of the treatment of
these patients in both groups is provided in Table 7.14.
TABLE 7.14: Cost of non-healers
Experimental group Control group
(ne=81 (nc=9)
Minimum R 864.39 R 441.67
Median R 1 646.71 R 2 284.53
I Maximum R 4 373.49 R 2 754.02 !
I
95% confidence interval: [-1033.48; 1058.17]
When comparing the treatment cost for the non-healers in both groups there
was no significant difference or discernable trend as can be seen by the
values of the 95% confidence interval [-1033.48; 1058.17] in Table 7.14.
7.5 Cost effectiveness
The total cost of treating patients in the experimental group who completed
the study was R23 052.02 (See Appendix 9). Fifteen out of 23 patients in this
group were completely healed (See Section 7.3.5.1). By dividing the healed
group (15) into the total treatment cost (R23 052.02) the cost of achieving
healing was R1 536.08 per patient in the experimental group. The 95%
confidence interval [869.1; 2204.5] here indicates the range of treatment cost
for the experimental group.
The total cost of treating patients in the control group who completed the
study was R22 824.71. Nine out of 18 patients in this group were completely
healed (See Section 7.3.5.1).
When dividing the healed group (9) into the total treatment cost, the cost to
achieve healing in the control group was R2 536.08 per patient. Similarly the
196
95% confidence interval [1644.4; 3427.7] here indicates the range of
treatment cost for the control group.
• Experimental (n=15) o Control (n=9)
GRAPH 7.1: Average treatment cost of healers
Since the values of confidence intervals for the respective groups overlap, we
have to assume that there \Vereno statisticaUyslgnmcarrtdëfferencesbebNeen
the groups as far as cost-effectiveness was concerned. However, as Graph
7.1 indicates, there does appear to be a tendency for the control treatment to
be more expensive and thus less cost-effective than the experimental
treatment.
7.6 Assessment of dressing acceptability
The acceptability of the wound treatment method to patients and caregivers
was assessed on completion of the study period by means of the Assessment
of Dressing Acceptability form.
197
7.6.1 Patients' assessment of dressing acceptability
Patients indicated their responses to specific statements related to the comfort
of the dressings on application and removal. In Table 7.15 the patients'
responses with regard to the comfort of the dressing on application indicate
that 14 (60,9%) of patients in the experimental group agreed that application
was comfortable as opposed to only 6 (33,4%) patients in the control group.
No one in the experimental group experienced discomfort on removal of the
dressing. However one (5,6%) patient in the control group expressed strong
discomfort on dressing removal. Notably a significant number of patients [9
(39,1%) in the experimental group and 11 (61,1%) in the control group] could
not report on the comfort of the dressing, as they were unresponsive due to
age-related dementia. These patients are indicated as not applicable in the
Table below.
TABLE 7.15:Patients' assessment of dressing application and removal
Assessment Experimental group Control group(ne=23) (nc=18)
Agree strongly 10 (43,5%) 2 (11,1%)
Agree a lot 2 (8,7%) 3 (16,7%)
Tend to agree 2 (8,7%) 1 (5,6%)
Tend to disagree 0 0
Disagree a lot 0 0
Disagree strongly 0 1 (5,6%)
Not applicable 9 11 (61,1%)
Agree strongly 0 1 (5,6%)
Agree a lot 0 0
Tend to agree 0 0
Tend to disagree 3 (13%) 3 (16,7%)
Disagree a lot 2 (8,7%) 2 (11,1%)
Disagree strongly 9 (39,1%) 1 (5,6%)
Not applicable 9 (39,1%) 11 (61,1%)
198
7.6.2 Caregiver's assessment of dressing acceptability
According to the data in Table 7.16 below, the caregiver strongly agreed that
application of dressings in 47,8% of patients in the experimental group was
easy as opposed to only one (5,6%) patient in the control group.
The overall ease of dressing application in the experimental group was much
higher. This was shown to be statistically significant 95% confidence interval
[1,6; 47,7]. Although the caregiver did not find it difficult to remove any
dressings, it does appear that dressing removal in the experimental group was
easier than in the control group.
TABLE 7.16:Caregiver's assessment of dressing application and
removal
Assessment Experimental group
(ne=23)
Agree strongly 11 (47,8%) 1 (5,6%)
Agree a lot 9 (39,1%) 2 (11,1%)
Tend to agree 2 (8,7%) 10 (55,6%)
Tend to disagree 1 (4,3%) 5 (27,8%)
Disagree a lot 0 0
Disagree strongly 0 0
Agree strongly 0 0
Agree a lot 0 0
Tend to agree 0 0
Tend to disagree 1 (4,3%) 10 (55,6%)
Disagree a lot 7 (30,4%) 6 (33,3%)
Disagree strongly 15 (65,2%) 2 (11,1%)
~,*",",Jn =- !.v~
199
7~6~3Caregiver's assessment of the durability of dressing
Dressing durability over the six-week study period was assessed by means of
a rating scale on the Assessment of Dressing Acceptability farm. The scale
ranged from one (not durable) to five (extremely durable).
Results of the assessment depicted in the graph below clearly show that
dressings used to treat patients in the experimental group were significantly
more durable than those used in the control group: the 95% confidence
interval [60,S; 94,2].
• Experimental (n=23)
D Control (n=18)
(1) Not Durable
(5) Extremely Durable
1 2 3 4 5
GRAPH 7.2: Durability of dressings
7.7 Conclusion
This chapter provided results and discussion of the data analysis. In the
following chapter final conclusions and recommendations wm be made along
with a discussion of the limitations of the study.
200
CHAPTER E~GHT
COU1lC~lUIS00U1lS, llmltatlons and recommendations
201
8.1 Introduction
In this chapter conclusions will be made, the limitations of the study discussed
and recommendations suggested.
8.2 Conclusions
The following conclusions with regard to the objectives of the study, namely
cost-effectiveness and acceptability, were drawn:
8.2.1 Cost-effectiveness
From the results of the data analysis presented in the preceding chapter it
may be concluded that over a six-week period more wounds in the
experimental group, treated with advanced wound care products and in
particular Smith & Nephew™ products, healed, than wounds in the control
group treated with the currently available wound care products.
As there were no significant statistical differences between the groups with
regard to the cost to achieve healing, it may be assumed that the advanced
wound care treatment method was not more expensive than the currently
used methods. However, there was a tendency for the currently used methods
to be more expensive. Furthermore, when the cost of treatment for all patients
who completed the study (healers and non-healers) was compared results
indicated a tendency for the advanced treatment method, using Smith &
Nephew™ products, to be less expensive.
202
Consequently it may be concluded that the results of this study indicate a
trend for advanced wound care methods to be more cost-effective than
currently used methods. Although these trends were not considered to be of
statistical significance, they are of clinical and practical importance.
8.2.2 Acceptability of treatment modalities
Conclusions regarding the assessment of the acceptability of these treatment
modalities to patients with pressure sores and their caregivers in the
community over a six-week period were the following:
8.2.2.1 Patients
In this study patients assessed the acceptability of dressings in terms of ease
as well as comfort of application and removal. Patients reported that dressings
used in the advanced wound care management method (Smith & Nephew™
products) were more acceptable than dressings (mostly gauze or
hydrocolloids) used in the current management methods.
8.2.2.2 Caregiver
The caregiver's assessment of dressing acceptability in terms of ease of
application and removal as well as durability over the six-week period indicate
that dressings used in the advanced wound care management method (Smith
& Nephew™ products) were significantly more acceptable than dressings
used in the current management methods.
203
8.3 Limitations of the study
The following limitations were identified in this study.
Over the 12-month period of data collection the researcher attempted to
recruit and include all eligible patients within the Bloemfontein community who
met the inclusion criteria. This eventually resulted in a sample population of 41
patients who completed the study. However, it is possible that a larger sample
size could have magnified the tendencies that were identified and ultimately of
statistical significance. However, a larger sample size would have had
additional implications such as an extended data collection period and
increased financial costs to the researcher. The lack of significant statistical
difference should also be considered in the light of a caveat by Feinstein
(1977:258) who stated the following: "Perhaps the most deleterious
consequence of using conventional statistical theory in modern clinical
science has been the widespread fantasy that a statistically significant
difference is a significant difference."
Despite efforts to obtain objective wound assessments, financial and practical
constraints limited the use of more sophisticated assessment methods to
monitor the rate of wound healing in the community setting.
The very nature of pressure sore aetiology is such that wounds will often
enlarge due to underlying tissue damage before healing can occur and be
evidenced as a visible reduction in wound size. Despite the successes of
other published trials in which patients were treated for six weeks (Banks &
Bale, 1994: 304), this may therefore have been too brief a period in which to
observe significant reduction in wound size. However, an extended treatment
period would have had financial implications.
204
8.4 Recommendations
The results of this study indicate that advanced wound treatment using
modern (Smith & Nephew™) products, often perceived to be more expensive,
tended to be more cost-effective than the currently used methods. The study
results also indicate a tendency for wounds treated with the advanced
treatment method to have a more rapid rate of healing. It therefore appears
that the advanced treatment method lends itself to better wound care practice
with financial benefits to individuals and institutions, yet there is still a
tendency for currently used traditional treatment methods to persist.
Consequently a paradigm shift towards a more advanced wound care
treatment method is needed. However, this will require training and education
about modern wound care to patients, caregivers and all health care
professionals.
In order to achieve this goal a formal course in wound care as a specialized
branch of nursing in South Africa needs to be established. Furthermore, as
successful wound care requires a multidisciplinary approach, wound care
education should be available to other health professionals to complement
their specialized knowledge and skills and thereby contribute to the clinical
practice of wound prevention and management.
During the 12-month data collection period of this study the researcher saw
evidence of an alarming lack of knowledge with regard to all aspects related to
the basic principles pressure sore prevention and treatment, not only in
patients and caregivers but also in health care workers, which included
professional nurses and physicians. The development of a comprehensive
best practice model or protocol for pressure sore prevention and treatment in
community settings could be of enormous value to wound care practitioners
and significantly benefit patients with pressure sores in the community.
205
In addition, a systematic, interdisciplinary and ongoing quality improvement
program needs to be developed and implemented to facilitate comprehensive,
consistent care that can be monitored, evaluated and changed as patient
conditions and current knowledge warrant.
Despite the advances in wound care products and much international
research on the topic over the past decade, a literature search revealed no
published community-based wound care trials in South Africa. This study
accentuates the need for more clinical research in wound care in South Africa,
in particular nurse-led community-based randomized clinical trials.
Accordingly, more attention in nursing education needs to be given to
quantitative research techniques and more specifically clinical trial
methodology in order to empower nurses to conduct and publish scientific
clinical research.
206
SUMMARYI OPSOMMING
207
SUMMARY
The purpose of this research project was to compare the cost-effectiveness
and acceptability of an advanced wound care management method, using
only Smith & Nephew™ wound care products, to that of currently used
methods and/or products as encountered by the researcher in the treatment of
pressure sores in the Bloemfontein community.
Prior to commencement the ethical committee of the Faculty of Health
Sciences, University of the Orange Free State, approved the study and its
procedures.
Fifty-eight patients who met the inclusion criteria (as stipulated in the research
protocol) were randomly allocated to an experimental group and a control
group. Patients in the experimental group were treated with Smith &
Nephew™ wound care products for six weeks. Patients in the control group
continued with their current treatment for the same period of time. The
researcher personally performed the dressing changes of all patients in both
groups free of charge. Furthermore the researcher attempted, where possible,
to address all those factors that might have impeded the healing process in
each patient. The characteristics and nature of each particular wound
determined the frequency of dressing changes. All wounds were assessed
and photographed by the researcher at weekly intervals for the six-week
period. The study continued uninterruptedly for 12 months until the required
sample size was achieved. The treatment methods of both groups were
compared in terms of cost-effectiveness and acceptability.
Analysis of the base-line data of patients on entry revealed no differences or
biases between the groups and they were therefore comparable. A number of
patients were withdrawn from the study as they died, moved from the
geographical area, were hospitalized or became infected. Ultimately forty-one
patients were included in the cost calculation.
208
Statistical analysis of the data using 95% confidence intervals revealed no
significant differences between the two groups with regard to the rate of
healing and cost of treatment. However, the confidence intervals indicated the
following discernable trends:
o More wounds in the experimental group healed than in the control group.
o The cost of treating wounds with the advanced treatment method
appeared to be lower than those treated with currently used methods.
o The cost to achieve healing in the experimental group tended to be lower
and therefore more cost-effective.
There was also a tendency for patients to find the advanced treatment using
Smith & Nephew™ wound care products, more acceptable than the currently
used more conventional methods. Moreover, results indicated that the
advanced Smith & Nephew™ dressings were significantly more durable.
The findings of this study suggest that individuals with pressure sores and
their caregivers in the community stand to benefit from using advanced wound
care methods, as they are appropriate, cost-effective and acceptable
treatment methods for the treatment of pressure sores. Consequently the
following recommendations are made:
o That a wound care course open to all health care professionals on wound
healing be instituted.
o That a protocol for the prevention and treatment of pressure sores be
developed.
o That attention be given to the education of nurses with regard to clinical
trial methodology.
o That nurse-led clinical wound care trials be encouraged.
209
OPSOMMING
Die doel van hierdie navorsingsprojek was om die koste-doeltreffendheid en
aanvaarbaarheid van 'n gevorderde wondsorg-bestuursmetode, met die
uitsluitlike gebruik van Smith & Nephew™ wondsorgprodukte, te vergelyk met
die metodes en/of produkte wat tans in gebruik is soos dit deur die navorser
vir die behandeling van druksere in die Bloemfontein gemeenskap aangetref
is.
Voor die aanvang van die navorsing het die etiese komitee van die Fakulteit
Gesondheidswetenskappe van die Universiteit van die Oranje-Vrystaat die
studie en sy prosedures goedgekeur.
Agt-en-vyftig pasiënte wat aan die insluitingskriteria, soos in die
navorsingsprotokol gestipuleer is voldoen het, is ewekansig aan 'n
eksperimentele en 'n kontrolegroep toegewys. Pasiënte in die eksperimentele
groep is vir ses weke met Smith & Nephew™ wondsorgprodukte behandel.
Pasiënte in die kontrolegroep het vir dieselfde tydperk met hulle behandeling
soos voorheen voortgegaan. Die navorser het persoonlik die wonde van albei
groepe versorg sonder om 'n fooi te hef. Die navorser het ook, sover moontlik,
gepoog om alle faktore wat moontlik die genesingsproses by elke pasiënt kon
strem, aan te spreek. Die aard en eienskappe van elke afsonderlike wond het
bepaal hoe dikwels die verbindsels verwissel is. Die navorser het al die wonde
elke week vir die ses-weke periode beraam en gefotografeer. Die studie het
ononderbroke vir 12 maande voortgeduur totdat die verlangde
steekproefgrootte bereik is. Die behandelingsmetodes van beide groepe is
vergelyk in terme van koste-doeltreffendheid en aanvaarbaarheid.
'n Analise van die basislyndata van die pasiënte by toetrede het geen verskille
of onewewigtigheid tussen die groepe aangetoon nie en hulle was derhalwe
vergelykbaar.
210
'n Aantal pasiënte is aan die studie onttrek omdat hulle gesterf het, uit die
geografiese streek getrek het, gehospitaliseer is of geïnfekteerd geraak het.
Uiteindelik is 41 pasiënte by die kosteberekening ingesluit.
Statistiese analise van die data met die gebruik van 95% vertouensintervalle
het geen beduidende verskille tussen die twee groepe ten opsigte van die
tempo van genesing en die koste van behandeling aangetoon nie. Die
vertrouensintervalle het egter die volgende waarneembare neigings getoon:
~ Meer wonde in die eksperimentele groep as in die kontrolegroep het
genees.
~ Dit wou voorkom of die koste van behandeling met die gevorderde
behandelingsmetode laer was as dié met die metodes wat tans in gebruik
is.
~ Die koste om genesing by die eksperimentele groep te bewerkstellig het
geneig om laer en daarom meer kostedoeltreffend te wees.
Daar was ook 'n neiging by die pasiënte om die gevorderde behandeling met
Smith & Nephew™ wondsorgprodukte meer aanvaarbaar te vind as die
konvensionele metodes wat tans in gebruik is. Verder toon die resultate dat
die gevorderde Smith & Nephew™ verbindsels beduidend duursamer as die
konvensionele tipes is.
Die bevindinge van hierdie studie dui daarop dat indiwidue met druksere en
hul versorgers in die gemeenskap voordeel kan trek uit die gebruik van
gevorderde wondsorgmetodes, aangesien hulle toepaslik, kostedoeltreffend
en aanvaarbare metodes vir die behandeling van druksere is. Gevolglik word
onderstaande aanbevelings gemaak:
~ Dat 'n wondsorgkursus wat vir alle professionele gesondheidsorgwerkers
oop is, ingestel word;
~ Dat 'n protokol vir die voorkoming en behandeling van druksere ontwikkel
word;
211
~ Dat aandag geskenk word aan die opleiding van verpleegkundiges in die
metodologie van kliniese proewe;
~ Dat verpleegkundige-geleide wondsorgproewe aangemoedig word.
212
ApPEND~X1
AdlvelJ't~seme01l1t
213
Gesoek: Alle persone ouer as 18 jaar met druksere, woonagtig in die
Bloemfontein area, wat sou belang stelom ingesluit te word in 'n
navorsingsprojek oor die behandeling van druksere. Geselekteerde persone
sal gratis behandeling vir 6 weke (in oorleg met hul geneesheer) ontvang. Vir
meer inligting skakel Nico Small by 0828568001 of (051) 446 3671.
Wanted: All persons over the age of 18 years living in the Bloemfontein area,
suffering from pressure sores who might be interested in enrolment in a
research project on the treatment of pressure sores. Selected individuals will
receive free treatment (in collaboration with their attending doctor) for 6
weeks. For more information call Nico Small at 0828568001 or (051) 446
3671.
214
Smith & Ne[p~ew Products
215
The following Smith & Nephew wound care products were used:
Intra5ite™ Gel
I A hydrogel containing a Graft- T-Starch copolymer.
I Allevyn TM Hydrocellular Polyurethane trilaminate structure with a non-adherent
Polyurethane Dressing contact layer, absorbent foam central layer and
waterproof outer layer.
Polyurethane trilaminate structure with a non-adherent
Allevyn™ Adhesive contact layer, absorbent foam central layer,
waterproof outer layer and an adhesive backing and
border.
I
! Allevyn TM Cavity Absorbent polyurethane foam chippings encased in a
perforated film.
Op5ite Flexigrid TM An adhesive polyurethane film dressing.
5urgipak™ (O.F .5. Pre-sterillsed, pre-packed wound trays. Each tray
i Dressing Tray) contains 1 plastic bag, 2 hand towels, 1 protection
sheet, 1 pair of latex gloves and 5 gauze swabs.
216
INTRASITE™ GEL APPLlPAK
PHARMACOLOGICAL ACTION
INTRASITE™ GEL APPLlPAK has no direct pharmacological action on the
body as it is designed as a topical application for wound management. It acts
by absorbing exudate from the wound surface, thereby preventing slough i
formation. The effective rehydrating action can produce rapid debridement of
necrotic wounds and removal of slough without damaging fragile granulation
tissue.
[INDICATIONS
INTRASITE™ GEL APPLlPAK is a dressing for cavity wounds, extravasation
injuries, venous ulcers and decubitus ulcers (pressure sores).
CONTRA-INDICATIONS
INTRASITE™ GEL APPLlPAK is for external use only and should not be
taken by mouth.
Hypersensitivity to any of the ingredients. Do not use on exposed muscle
tendon or bone. Do not use on deep partial thickness and full thickness burns.
WARNINGS
The initial application of INTRASITE™ GEL APPLlPAK should be under the
direction of a health professional.
For external use only.
DOSAGE AND DIRECTIONS FOR USE
Prepare the wound site by irrigating with a sterile solution e.g. saline.
Remove cap and swab the nozzle area of the pack with a suitable antiseptic
swab.
Snap the patterned tip off the nozzle.
1. Keeping the nozzle tip clear of the wound surface, gently press the bulb
of the pack to dispense gel into the wound. Smooth over the surface of
the wound, ensuring a minimum gel depth of 5 mm.
2. Cover the wound with a secondary dressing.
217
OPSITE™ FLEXIGRID
DESCRIPTION
OPSITE FLEXIGRID is a transparent film dressing, comprised of a I
polyurethane film with acrylic adhesive. The film is supported on a flexible grid
carrier to provide a simple application system.
MODE OF ACTION
When used on wounds, the OPSITE film creates a moist environment by
retaining exudate. The film is moisture vapour permeable, allowing excess
exudate to evaporate and preventing skin maceration. OPSITE FLEXIGRID is
waterproof and aids in the prevention of bacterial contamination of the wound.
The film is highly extensible and conformable and is easily adaptable to
awkward areas. The grid carrier can be used to map wounds to monitor the
healing process.
INDICATIONS
OPSITE FLEXIGRID is indicated for:
The management of superficial wounds (eg. Superficial pressure sores, minor
burns, abrasions).
The protection of fragile skin.
The retention of primary dressings (eg. INTRASITE™ Gel, ALLEVYN™
Cavity).
The fixation of catheters.
INSTRUCTIONS FOR USE
1. Clean and dry the application area.
2. Remove the backing paper and side tab.
3. Apply the dressing and smooth down.
4. If required, trace the wound on the green squared carrier before removing.
5. Remove the carrier.
6.To remove the dressing, lift one corner and gently stretch parallel to the
skin. The dressing may be left in place for up to 14 days.
PRECAUTIONS FOR USE
OPSITE FLEXIGRID may be used on clinically infected wounds if the
following precautions are followed:
The patient should be under medical/clinical supervision.
The dressing should be changed daily.
The patient should be receiving suitable systemic treatment.
Immuno-compromised patients and diabetic patients may require extra
supervision. Care should be taken to avoid skin damage on repeated
applications on patients with thin or fragile skin.
218
ALLEVYN ™ CAVITY
~
I
DEEP WOUND DRESSING
DESCRIPTION
ALLEVYN CAVITY wound dressing consists of highly absorbent hydrocellular
granules encapsulated in a soft, perforated honeycomb film. Each dressing is
individually packed and sterilised.
MODE OF ACTION
ALLEVYN CAVITY absorbs exudate while maintaining a moist wound
environment. It packs the wound, physically preventing premature wound closure
and is non-adherent to the wound surface.
INDICATIONS
Cavity wounds including pressure sores, pilonidal sinuses, surgical I
excisions/incisions to:
- manage wounds prior to delayed primary closure and
- wound healing via secondary intention.
INSTRUCTIONS FOR USE
1. Clean the wound in accordance with normal procedures.
2. Select an appropriately sized dressing or combination of dressings and insert
into the cavity using sterile blunt forceps or gloved hands.
3. Make a note of the number of dressings used in each wound on the patient's
records.
4. Hold the dressing(s) in place using a suitable retention dressing, eg. OPSITE™
FLEXIGRID™. Alternatively, an absorbent dressing pad, eg. MULTISORB™ or
MELOLlN™ may be used in conjunction with a fixative sheet, eg. HYPAFIX™,
or a bandage, eg. TENSOPLUS™ Lite. This is particularly advised when the
skin around the wound is of a very fragile or friable nature.
Note A: Where necrotic or sloughy tissue is present in the wound, ALLEVYN
Cavity may be used in conjunction with INTRASITE™ Gel.
Note B: ALLEVYN cavity may be used with topical liquid antiseptics if required.
Also see Precautions section.
FREQUENCY OF CHANGE
ALLEVYN CAVITY can be left in place for up to seven days, depending on the
clinical condition of the wound.
DRESSING REMOVAL
Remove secondary dressings and carefully remove ALLEVYN CAVITY dressings
using either blunt forceps or gloved hands.
PRECAUTIONS
ALLEVYN CAVITY dressings should not be re-used. Do not soak ALLEVYN
CAVITY dressings in oxidising agents such as hypochlorite solutions (eg.
EUSOL) or hydrogen peroxide, as these can break down the absorbent
polyurethane component of the dressing.
219
ALLEVYN™
HYDROCELLULAR DRESSING
DESCRIPTION
ALLEVYN HYDROCELLULAR dressing combines an absorbent hydrocellular
pad sandwiched between a perforated non-adherent wound contact layer and a I'
waterproof outer film.
MODE OF ACTION
ALLEVYN HYDROCELLULAR dressing provides a moist wound healing
environment. The dressing is easy to apply and remove. The absence of
adhesive makes the dressing especially suitable for use on fragile skin.
INDICATIONS AND PRODUCT CLAIMS
Wound management by secondary intention on shallow, granulating wounds.
INSTRUCTIONS FOR USE
1. Clean the wound in accordance with normal procedures.
2. Select an appropriate size.
3. Prepare and clean the skin surrounding the wound area by removing excess
moisture. Any excess hair should be clipped to ensure close approximation to
the wound.
4. Apply the white, patterned face to the wound and secure with a dressing
retention sheet (eg. HYPAFIX™), tape or bandage. ALLEVYN dressings can
be used in conjunction with compression therapy on venous leg ulcers.
5. ALLEVYN dressing can be cut, especially to dress wounds on heels, elbows
and other awkward areas.
FREQUENCY OF CHANGE
During the early stages of treatment, ALLEVYN dressings should be inspected
frequently; dressings can be left in place undisturbed for up to 7 days, or until
exudate is visible and approaches 1.5 cm from the edge of the dressing. The film
backing is a waterproof outer layer that aids in the prevention of bacterial
contamination of the wound. See below for further information.
DRESSING REMOVAL
To remove ALLEVYN dressings, remove dressing or bandage and lift the
dressing away from the wound.
PRECAUTIONS
ALLEVYN dressings should not be reused. Do not use ALLEVYN dressings with
oxidising agents such as hypoclorite solutions (eg. EUSOL) or hydrogen
peroxide, as these can break down the absorbent polyurethane component of the
dressing. Reddening of the skin around the wound following the use of ALLEVYN
dressings has been reported rarely. In some cases this relates to irritation of
fragile skin, in others, wound exudate remaining in contact with normal skin for
prolonged periods may be the cause. Infrequently, cases of sensitivity to the I
dressing have also been reported. If reddening or sensitisation occur, discontinue
use and consult a healthcare professional.
220
ALLEVYN™ ADHESIVE
HYDROCELLULAR DRESSING
DESCRIPTION
ALLEVYN ADHESIVE dressing combines a centrally located absorbent
hydrocellular pad sandwiched between a perforated adherent wound contact
layer and a waterproof outer film.
MODE OF ACTION
ALLEVYN ADHESIVE dressing provides a moist wound healing environment.
The dressing is easy to apply and remove.
INDICATIONS AND PRODUCT CLAIMS
Wound management by secondary intention healing on shallow, granulating
wounds.
INSTRUCTIONS FOR USE
1. Clean the wound in accordance with normal procedures.
2. Select an appropriate size.
3. Prepare and clean the skin surrounding the wound area by removing excess
moisture. Any excess hair should be clipped to ensure close approximation to
the wound. SKIN-PREP™ wipes may be used prior to application of ALLEVYN
ADHESIVE dressing where fragile skin is involved.
4. Remove the outermost protector paper from ALLEVYN ADHESIVE dressing
and anchor the dressing at one side.
5. Smooth the dressing over the wound, removing the remaining protector paper.
Ensure the dressing is securely in place and the edges are not wrinkled.
6. ALLEVYN dressing can be cut, especially to dress wounds on heels, elbows
and other awkward areas.
7. When positioning ALLEVYN ADHESIVE SACRUM DRESSINGS, place the
narrow end of the dressing a minimum of 2 cm above the anal sphincter, then
smooth the dressing over the sacrum.
FREQUENCY OF CHANGE
During the early stages of treatment, ALLEVYN ADHESIVE dressings should be
inspected frequently; dressings can be left in place undisturbed for up to 7 days,
or. until exudate is visible and approaches 2 cm from the edge of the dressing.
The film backing is a waterproof outer layer that aids in the prevention of bacterial
contamination of the wound. See below for further information.
DRESSING REMOVAL
To remove ALLEVYN dressings, lift one corner of the dressing and stretch the
dressing gently away from the wound.
Sacral dressings should be removed from the top edge and down towards the
anus to minimise the chance of transmitting infection.
221
PRECAUTIONS
ALLEVYN ADHESIVE dressings should not be reused. Do not use ALLEVYN '
ADHESIVE dressings with oxidising agents such as hypoclorite solutions (eg.
EUSOL) or hydrogen peroxide, as these can break down the absorbent
polyurethane component of the dressing. In common with all adhesive products,
some rare cases of irritation and/or maceration of the skin surrounding the wound
have been reported. Infrequently, cases of sensitivity to the dressing have also
been reported. It should be noted that inappropriate use or too frequent dressing
changes, particularly in patients with fragile skin, can result in skin irritation or
stripping. If reddening or sensitisation occur, discontinue use and consult a
healthcare professional.
222
ApPEND~X 3
Products used ~1T1ftl~e COlT1lftIrO~ glrOlLOlP
223
The following cleansers, topical treatments and dressings as encountered by
the researcher in the community, were used on the wounds of patients in the
control group that completed the study. A reference to sections in the
literature where each item is discussed, is provided in brackets.
Cleansers
o Milton™ (See Section 4.5.2.1 [cl)
o Saline (See Section 4.5.2.1 [hl)
Topical treatments
o Acriflavin (See Section 4.5.4.2)
o Bactrazine ™ (See Section 4.5.4.1)
o Tea tree oil (See Section 4.5.4.4)
o Flagyl ™ (See Section 4.5.4.1)
o Aqueous cream (See Section 4.5.4)
o Betadine™ (See Section 4.5.2.1[e])
o Bactrazine ™ (See Section 4.5.4.1)
o Johnson & Johnson Nu-gel™ hydrogel (See Section4.5.5.3)
o Aserbine™ cream (See Section 4.5.3.3)
Wound dressings
o Gauze (See Section 4.5.5.9)
o Cotton wool (See Section 4.5.5.9)
o Coloplast™ ulcer dressing (See Section 4.5.5.2)
o Coloplast™ transparent dressing (See Section 4.5.5.2)
41 Bactigrass™ (See Section 4.5.5.7)
o Jelonet™ (See Section 4.5.5.7)
• 3M™ Island dressing (See Section 4.5.5)
41 3M Transparent dressing (See Section 4.5.5.1)
224
tnstrurnents used tor data colteetton
225
1. Patient number:
I I
1-3
2. Date:
4-7
3. Gender:
D
8
4. Age:
I I
9-10
5. Allergies:
5.1. _
11-12
5.2. _ I I
13-14
5.3. _ I I
15-16
5.4. _ I I
17-18
5.5. _
1 1
19-20
6. Weight (in light clothing):
1'--------L----=-,1:-=-,1
21-23
7. Length (without shoes):
,---,----,----,I cm 1 1
24-26
226
8. Wound site:
I I
(Indicate on the figures below) 27-28
Anterior Posterior
227
1. Patient number:
I I
1-3
2. Date:
4-7
3. Weight (in light clothing):
I I
8-10
4. Braden Pressure Sore Risk assessment score:
I I
11-12
5. Wound duration (since onset):
'----'-_'-----'1 Weeks I I
13-15
6. Number of days dressing is in place:
o CJ
16
7. Indicate the condition of the wound dressing:
1 In place and intact
2 In place with loose edges
3 In place with crumpled edges
4 Dressing has failed to stay in place (Include a report in the case record)
5 Other Specify: _ CJ
17
8. Wound dimensions:
8.1 Max length
'----'-_'-----'1 mm I I
18-20
8.2 Max width
I I
21-23
228
8.3 Max depth
Imm I I
24-26
8.4 Wound volume
I cc I I
27-29
8.5 Tracing:
I~ I ~~s o30
9. Pressure sore classification according to the Sterling Pressure Sore Severity Scale:
,---,-_,,--__'____JI Stage I I
31-34
10. Level of exudate:
1 Hiqh*
2 Medium o
3 Low 35
10.1 Amount of exudate change:
1 Same as last assessment
2 Increasing*
3 Decreasinq
4 Unknown - first assessment o
36
10.2 Type of exudate:
1 Bloody*
2 Serous
3 Serosanguineous o
4 Combination/ Other Specify: _ 37
11. Appearance of the wound bed:
11.1 Necrotic/black tissue*
L____J__...l.___J1 % I I
38-40
11.2 Slough/yellow tissue*
'----'-_-'---Jl % I I
41-43
1 Asterixes (*) refer to observations which may indicate wound infection.
229
11.3 Granulation/red tissue
I I
44-46
11.4 Epitheliating/pink tissue
L..,_----'- _ __t_--'I % I I
47-49
12. Surrounding skin/ wound margin:
1 Intact 50
2 Erythema* 51
3 Indurated* 52
4 Macerated* 53
5 Oedematous* 54
6 Localised heat around wound margin* 55
7 Fragile* 56
8 Drv-scalinq 57
13. Pain:
1 No pain
2 At dressing change*
3 Intermittent* CJ
4 Persistent" 58
13.1 Degree of pain (encircle the number under the appropriate facial expression)
M\9M8~~~~ ~.
o \3JI 2 3 5
Source: Wong-Bakerfaces rating scale. 1997. AJN. 97(7): 19
CJ
59
14. Factors that may delay healing:
1 Poor nutrition 60
2 Impaired circulation 61
3 Impaired sensation 62
4 Foreign bodies 63
5 Dehydration 64
6 Non-compliance 65
7 Smoking 66
8 Underlying disease 67
9 Pharmacological agents 68
10 Impaired mobility 69
11 Complementary medicines 70
12 Anaemia 71
13 Mechanical forces 72
14 Systemic infection 73
230
15. Medication (including over-the-counter drugs and complementary medicines) used in the
last two weeks:
1. __ I I
74-75
2. __ I I
76-77
3. __ I I
78-79
4. __ I I
1-2
5. __ I I
3-4
16. Cleansing solution(s) used:
1. __ I I
5-6
2. __ I I
7-8
3. __ I I
9-10
4. __ I I
11-12
5. __ I I
13-14
17. Topical treatment applied:
1. __ I I
15-16
2. __ I I
17-18
3. __ I I
19-20
4. __ I I
21-22
5. __ I I
23-24
18. Dressing(s) used:
1. __ I I
25-26
2. __ I I
27-28
3. __ I I
29-30
4. __ I I
31-32
5. __ I I
33-34
231
19. Last dressing applied on:
19.1 Date:
I I
35-38
20. Duration of wound care:
Started:
I I
39-43
Ended:
I I
44-48
21. Are any symptoms of an adverse reaction present?
D
49
21.1 If yes, describe symptoms.
1. I I
50-51
2. I I
52-53
3. I I
54-55
4. I I
56-57
5. I I
58-59
22. Photograph of the wound:
22.1 Photo number: (patient number/ disk number - file number)
22.2 Additional comments:
1. I I
60-61
2. I I
62-63
3. I I
64-65
4. I I
66-67
5. I I
68-69
232
23. Is the patient continuing to partake in the study?
I ~ I CJ~~s 70
23.1 If no, state reason/s for discontinuation.
1. I I
71-72
2. I I
73-74
3. I I
75-76
4. I I
77-78
5. I I
79-80
24. Case record, including adverse event(s) and/or incident(s):
* Observations which may indicate infection.
233
1. Patient number:
I I
1-3
2. Date:
4-7
3. Indicate your responses to the following statements:
3.1 'Application of the dressing was comfortable.'
1 Agree strongly
2 Agree a lot
3 Tend to agree
4 Tend to disagree
5 Disagree a lot
6 Disagree strongly CJ
7 Not applicable (no sensation) 8
3.2 'Removal of the dressing was uncomfortable.'
1 Agree strongly
2 Agree a lot
3 Tend to agree
4 Tend to disagree
5 Disagree a lot
6 Disagree strongly CJ
7 Not applicable (no sensation) 9
The following questions are to be completed by the caregiver referring to the aforementioned patient.
4. Indicate your responses to the following statements:
4.1 'Application of the dressing was easy.'
1 Agree strongly
2 Agree a lot
3 Tend to agree
4 Tend to disagree
5 Disagree a lot CJ
6 Disagree strongly 10
234
4.2 'Removal of the dressing was difficult.'
1 Agree strongly
2 Agree a lot
3 Tend to aqree
4 Tend to disagree
5 Disagree a lot CJ
6 Disagree strongly 11
5. Indicate on the rating scale below how durable the wound dressing was over the last 6
weeks, considering the extraneous factors applicable to this patient?
Not Durable 1,---~_,--_:2=---_j____:3=---_.J__4"':""__.J.__.=.5_J1 Extremely Durable CJ
12
235
1. Patient number:
I I
1-3
2. Date:
4-7
3. Number of days dressing is in place:
D CJ
8
4. Indicate the condition of the wound dressing:
1 In place and intact
2 In place with loose edges
3 In place with crumpled edges
4 Dressing has failed to stay in place (Include a repott in the case record)
5 Other Specify: _ CJ
9
5. Level of exudate:
1 High*
2 Medium CJ
3 Low 10
5.1 Amount of exudate change:
1 Same as last assessment
2 Increasing*
3 Decreasing
4 Unknown - first assessment CJ
11
5.2 Type of exudate:
1 Bloody*
2 Serous
3 Serosanguineous CJ
4 Combination/ Other Specify: _ 12
6. Appearance of the wound bed:
6.1 Necrotic/black tissue*
I I
13-15
236
6.2 Slough/yellow tissue"
1% I 1
16-18
6.3 Granulation/red tissue
1% 1
19-21
6.4 Epitheliating/pink tissue
1% 1 1
22-24
7. Surrounding skin/ wound margin:
1 Intact 25
2 Erythema" 26
3 lndurated'' 27
4 Macerated" 28
5 Oedematous" 29
6 Localised heat around wound marqin" 30
7 Fraqile" 31
8 Dry-scaling 32
8. Pain:
1 No pain
2 At dressing chance'
3 Intermittent" CJ
4 Persistent" 33
8.1 Degree of pain (encircle the number under the appropriate facial expression).
~.
\5)
5
Source: Wong·Baker faces rating scale. 1997. A.JN. 97(7): 19
CJ
34
9. Cleansing solution(s) used:
1. _
1 1
35-36
2. _
1 1
37-38
3. _
1 1
39-40
4. _
1 1
41-42
5. _
1 1
43-44
237
10. Topical treatment applied:
1. __ I I
2. __ 45-46I I
47-48
3. __ I I
49-50
4. ___ I I
51-52
5. __ I I
53-54
11. Dressing(s) used:
1. __ I I
2. __ 55-56I I
3. __ 57-58I I
59-60
4. __ I I
5. __ 61-62I I
63-64
12. Last dressing applied on:
12.1 Date:
I I
65-68
13. Duration of wound care:
Started:
I I
69-73
Ended:
I I
74-78
238
14. Case record, including adverse event(s) and/or incident(s):
o Observations which may indicate infection.
239
COO1lse01ltForms
240
A COMPARATIVE ANALYSIS OF PRESSURE SORE TREATMENT
MODALITlES IN COMMUNITY SETTINGS
Investigator: Mr. N. Small
Pressure sores can effect all people at any age. However, the elderly, the bedridden
and the physically disabled are considered to be at greatest risk for pressure sore
development. Despite preventive measures, the occurrence of pressure sores
remains a costly health problem. The financial cost of treatment is high, while the
cost in terms of pain and suffering to the patient is incalculable.
The purpose of this research project is to compare the cost-effectiveness and
acceptability of Smith & Nephew™ wound care products to those of other methods
and/or products in the treatment of pressure sores in the community. Forty subjects
who meet the inclusion criteria (as stipulated in the research protocol) will be
randomly allocated to an experimental group and a control group. Subjects in the
experimental group will be treated with Smith & Nephew™ wound care products for
six weeks free of charge. Subjects in the control group will continue with their current
treatment for the same period of time. The investigator will personally perform the
dressing changes of all patients in both groups free of charge. The characteristics
and nature of each particular wound will determine the frequency of dressing
changes. All wounds will be assessed and photographed by the investigator at
weekly intervals for the six-week period. The treatment methods of both groups will
be compared in terms of cost-effectiveness and acceptability. Results of this study
will assist individuals with pressure sores and their caregivers in the community in
their choice of an appropriate, cost-effective and acceptable treatment method.
The study and its procedures have been approved by the ethical committee of the
Faculty of Health Sciences, University of the Orange Free State. Risks involved in
this research are no more than those associated with your current treatment
method(s). However, you will be carefully monitored throughout the trial period and
should any adverse event occur as a result of the dressings, the treatment will be
discontinued and your wound managed appropriately. You are free to ask any
241
questions about the study or about being a subject and you may call Mr. Small at
0828568001 if you have any further questions.
Photographs taken of the wound(s) will be used for research and educational
purposes as well as for any articles that may stem from the research. Should any
photograph reveal your face, this area will be blacked out to protect your identity.
However, the investigator will ensure that the wound photography and all other study
data will not be linked to your name. Your identity will not be revealed while the study
is being conducted or when the study is reported or published. All study data will be
collected by the investigator, stored in a secure place, and not shared with any other
person without your permission.
Your participation in this study is voluntary; you are under no obligation to participate.
You have the right to withdraw at any time without penalty.
I, , have read this consent form and voluntarily
consent to participate in this study. I have been given a copy of this consent form.
Subject's signature Date
I have explained this study to the above subject and have obtained his/her voluntary
informed consent.
Investigator's signature Date
242
'N VERGELYKENDE ANALISE VAN
DRUKSEERBEHANDELlNGSMETODES IN DIE GEMEENSKAP
Navorser: Mnr. N. Small
Druksere kan by enige persoon van enige ouderdom voorkom. Die groepe wat egter
die grootste risiko loop om druksere te ontwikkel is bejaardes, gestremdes en
bedlêendes. Ten spyte van voorsorgmaatreëls bly die voorkoms van druksere 'n
frustrerende gesondheidsprobleem. Die finansiële koste van behandeling is duur
terwyl die koste in terme van menslike pyn en lyding onberekenbaar is.
Die doel van hierdie navorsingsprojek is om die koste-effektiwiteit en
aanvaarbaarheid van Smith & Nephew™ se wondsorgprodukte as
drukseerbehandelingsmetode in die gemeenskap, met dié van ander
behandelingsmetodes/produkte te vergelyk. Veertig persone wat aan die
insluitingskriteria voldoen (soos uiteengesit in die navorsingsprotokol), sal ewekansig
aan 'n eksperimentele- en 'n kontrole groep toegewys word. Persone in die
eksperimentele groep sal gratis behandeling vir ses weke met Smith & Nephew TM se
produkte ontvang. Dié in die kontrole groep sal voortgaan met hul huidige
behandeling vir dieselfde periode. Die navorser onderneem om persoonlik die
wondbehandeling van al die pasiënte, in beide groepe, vir die ses weke gratis te
behartig. Die aard en eienskappe van elke wond sal bepaal hoe dikwels
wondbehandeling gedoen sal word. Die navorser sal alle wonde weekliks beraam en
fotografeer. Die behandelingsmetodes van beide groepe sal dan vergelyk word in
terme van koste-effektiwiteit en aanvaarbaarheid. Resultate van hierdie
navorsingsprojek sal individue met druksere en hul versorgers in die gemeenskap
help in hul keuse van 'n toepaslike, koste-effektiewe en aanvaarbare
behandelingsmetode.
Die navorsingsprojek is goedgekeur deur die etiese komitee van die Fakulteit
Gesondheidswetenskappe van die Universiteit van die Oranje Vrystaat. Risiko's
verbonde aan die navorsing is nie meer as dié wat met u huidige behandeling
geassosieer word nie.
243
U sal egter deurlopend gedurende die navorsingsperiode gemonitor word en sou
enige nadelige effek as gevolg van die eksperimentele behandeling voorkom, sal die
behandeling onmiddellik gestaak word en u wond op 'n toepaslike alternatiewe
metode behandel word. Enige vrae wat u omtrent die navorsing sou hê kan u aan
Mnr. Small by 0828568001 rig.
Foto's van die wonde sal vir navorsing, opvoedkundige doeleindes en publikasies
wat uit die navorsingsprojek mag spruit, gebruik word. Indien enige pasiënt se gesig
op 'n foto sou verskyn, sal die gesig area verdonker word om te verseker dat die
pasiënt nie herken sal word nie. Die navorser verseker egter dat die foto's en alle
ander inligting nie aan 'n naam gekoppel sal word nie. U identiteit sal dus nie tydens
of na die navorsing onthul of bekend gemaak word nie. Alle inligting wat deur die
navorser versamel word, salop 'n veilige plek geberg word. Geen inligting sal met 'n
ander persoon gedeel word sonder u uitdruklike toestemming nie.
U deelname aan die navorsingsprojek is vrywillig; u is onder geen verpligting om deel
te neem nie. U behou ook die reg om u te enige tyd van die projek te onttrek, sonder
dat u hoegenaamd benadeel of verkwalik sal word.
Ek, , het hierdie toestemmingsvorm gelees
en verleen hiermee vrywillig toestemming om aan die navorsingsprojek, wat deur
Mnr. N. Small geloods word, deel te neem. Ek het 'n afskrif van hierdie
toestemmingsvorm ontvang.
Handtekening van proefpersoon Datum
Ek, N. Small, het die omvang en prosedures van die navorsingsprojek aan die
bogenoemde proefpersoon verduidelik en sy/haar vrywillige, ingeligte toestemming
verkry.
Handtekening van navorser Datum
244
MAQEBA A SA FOLENG KA HARA SET JHABA:
PAPISO YA PHUPUTSO MEKGWENG YA PHEKO YA OISO TSE
BAKWANG KE KGATELLO
Dipatlisiso ka: Mong. N Small
Diso tse bakwang ke kgatello di ka ama batho bohle mme ba le dilemong dife kapa
dife. Le ha ho le jwalo, maqheku, bakudi ba kulelang diphateng le diqhwala ke bona
ba angwang haholo ke diso tse bakwang ke kgatello. Le hoja ho na le mekgwa ya
thibelo ya tsona, ho ba teng ha diso tse bakwang ke kgatello ho baka bothata bo
boholo maemong a bophelo. Ho fumantshwa pheko ho batla tjhelete e ngata haholo,
ha ka lehlakoreng le leng bohloko le ho sotleha ha mokudi e le ntho e sa tlo
lekanngwa.
Maikemisetso a projeke ena ya dipatlisiso ke ho lekalekanya maemo a bokgoni le
kamohelo ya disebediswa tsa pheko tsa ba ha Smith & Nephew ha di bapiswa le
mekgwa e meng le tse sebediswang ha ho phekolwa diso tse bakwang ke kgatello
ka hara setjhaba. Batho ba 40 ba tla bewa tlasa diteko tsa pheko mme ba
ikamahanya le maemo Uwalo ka ha a beilwe metjheng ya dipatlisiso), ka ho
fapafapana ba tla hlahlojwa ke sehlopha se etsang diteko le sehlopha se nang le
taolo. Batho bao ho etswang diteko ka bona mme ba le sehlopheng se etsang diteko
tsa pheko ya maqeba ka disebediswa tsa Smith & Nephew, ba tla fumantshwa kalafo
dibekeng tse tsheletseng ntle le tefo kapa mahala. Batho ba sehlopheng sa taolo
bona ba tla tswella ka ho fumantshwa kalafo eo ba ntseng ba e fumana nakong eo
ya dibeke tse tsheletseng. Le ha ho le jwalo, motho ya hlahlobang dihlopheng tseo
tse pedi ke yena ka seqo sa haé ya tla tlamella maqeba ntle le tefo ya letho. Mofuta
wa leqeba ka leng le maemo a Iona, ke tsona tse tla bontsha hore na leqeba le
tlamellwe le ho hlokomelwa jwang. Maqeba ohle a tla hlahlojwa le ho nkuwa
ditshwantsho bekeng ka nngwe nakong ena ya dibeke tse tsheletseng. Mekgwa ya
phumantsho ya pheko ho tswa dihlopheng tsena tse pedi e tla bapiswa bakeng sa
hore na e phethahetse le hore e a amohelwa. Sephetho sa patlisiso ena se tla thusa
batho ba nang le diso tse bakwang ke kgatello le bahlokomedi ba bona ka hara
setjhaba kgethong ya bona ya mokgwa wa pheko eloketseng, e phethahetseng le e
amohelehang.
245
Dipatlisiso tsena mmoho le metjha ya tsona di dumelletswe ke komiti eikarabellang
ho tsa boitshwaro ha ho etswa diphuputso, e mane Lekaleng la Mahlale a Bophelo
Unibesithing ya Freistata. Mathata a teng patlisisong ena ha se a mang ho feta a
ntseng a le teng a amanang le mekgwa ya hao ya pheko/kalafo. Le ha ho le jwalo, 0
tla bewa leihlo ka tlhokomelo nakong yohle ya diteko mme ha ho ka hlaha tshita ka
lebaka la ho tlamellwa diso, pheko kapa kalafo e tla emiswa mme leqeba la hao le
hlahlojwe hantle. 0 amohelehile hore 0 ka botsa potso efe kapa efe e mabapi le
patlisiso kapa ho ba e mong ya bewang ditekong mme ha 0 na le dipotso tse ding 0
ka letsetsa Mong. Small nomorong ena: 0828568001.
Ditshwantsho tsa maqeba tse nkilweng ka khamera di tla sebedisetswa dipatlisiso le
maikemisetso a thuto esita le mahlasedi a ditaba a tla hlahiswa ke dipatlisiso. Haeba
setshwantsho se ka hlahisa sefahleho sa hao, karoio eo ya sefahleho e tla takwa ka
botsho hore se se bonahale le ho sireletsa botho ba hao. Le ha ho le jwalo, motho ya
etsang dihlahlobo 0 tla netefatsa hore ditshwantsho tsa maqeba le tsohle tse
amanang le wena ha di na ho ba le lebitso la hao. Botho ba hao kapa setshwantsho
sa hao ha se na ho hlahiswa nakong ya phuputso kapa ha ho fanwa ka sephetho
kapa se tsebahatswa. Sephetho sohle sa dipatlisiso se tla bokellwa ke ya etsang
dihlahlobo, di bewe tulong e bolokehileng mme di ke ke tsa arolelanwa kapa tsa
tsebiswa motho e mong ntle le tumello ya hao. Ho ba le seabo ha hao patlisisong
ena ke ka ho rata ha hao; ha 0 a qobelleha hore 0 ka ba le seabo. 0 na le tokelo ya
ho ikgula patlisisong nako efe kapa efe ntle le hore 0 ahlolwe.
Nna, , ke badile foromo ena e fanang ka tumello mme ke intsha
sehlabelo ka ho rata ha ka ho ba le seabo patlisisong ena. Ke filwe khopi ya foromo
ena e fanang ka tumello.
LebitsolT shaeno/Peleketso Mohla
Ke hlalositse patlisiso ena mothong ya boletsweng ka hodimo mme ka batla
kutlwisiso le tumello ya hae.
Ya fuputsang ·Mohla
246
ApPEND~X6
247
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Recommendations guiding physicians
in biomedical research involving human subjects
Adopted by the ia" World Medical Assembly
Helsinki, Finland, June 1964
And amended by the
29th World Medical Assembly, Tokyo, Japan, October 1975
ss" World Medical Assembly, Venice, Italy, October 1983
41st World Medical Assembly, Hong Kong, September 1989
and the
48th General Assembly, Somerset West, Republic of South Africa, October 1996
INTRODUCTION
1. It is the mission of the physician to safeguard the health of the people. His or her
knowledge and conscience are dedicated to the fuifiIIment of this mission.
2. The Declaration of Geneva of the World Medical Association binds the physician
with the words, "The Health of my patient will be my first consideration," and the
International Code of Medical Ethics declares that, "A physician shall act only in
the patient's interest when providing medical care which might have the effect of
weakening the physical and mental condition of the patient."
3. The purpose of biomedical research involving human subjects must be to
improve diagnostic, therapeutic and prophylactic procedures and the
understanding of the aetiology and pathogenesis of disease.
4. In current medical practice most diagnostic, therapeutic or prophylactic
procedures involve hazards. This applies especially to biomedical research.
5. Medical progress is based on research which ultimately must rest in part on
experimentation involving human subjects.
248
6. In the field of biomedical research a fundamental distinction must be recognized
between medical research in which the aim is essentially diagnostic or
therapeutic for a patient, and medical research, the essential object of which is
purely scientific and without implying direct diagnostic or therapeutic value to the
person subjected to the research.
7. Special caution must be exercised in the conduct of research which may affect
the environment, and the welfare of animals used for research must be
respected.
8. Because it is essential that the results of laboratory experiments be applied to
human beings to further scientific knowledge and to help suffering humanity, the
World Medical Association has prepared the following recommendations as a
guide to every physician in biomedical research involving human subjects. They
should be kept under review in the future. It must be stressed that the standards
as drafted are only a guide to physicians all over the world. Physicians are not
relieved from criminal, civil and ethical responsibilities under the laws of their own
countries.
I. BASIC PRINCIPLES
1. Biomedical research involving human subjects must conform to generally
accepted scientific principles and should be based on adequately performed
laboratory and animal experimentation and on a thorough knowledge of the
scientific literature.
2. The design and performance of each experimental procedure involving human
subjects should be clearly formulated in an experimental protocol which should
be transmitted for consideration, comment and guidance to a specially appointed
committee independent of the investigator and the sponsor provided that this
independent committee is in conformity with the laws and regulations of the
country in which the research experiment is performed.
3. Biomedical research involving human subjects should be conducted only by
scientifically qualified persons under the supervision of a clinically competent
medical person. The responsibility for the human subject must always rest with a
249
medically qualified person and never rest on the subject of the research, even
though the subject has given his or her consent.
4. Biomedical research involving human subjects cannot legitimately be carried out
unless the importance of the object is in proportion to the inherent risk to- the
subject.
5. Every biomedical research project involving human subjects should be preceded
by careful assessment of predictable risks in comparison with foreseeable
benefits to the subject or to others. Concern for the interests of the subject must
always prevail over the interests of science and society.
6. The right of the research subject to safeguard his or her integrity must always be
respected. Every precaution must be taken to respect the privacy of the subject
and to minimize the impact of the study on the subject's physical and mental
integrity and on the personality of the subject.
7. Physicians should abstain from engaging in research projects involving human
subjects unless they are satisfied that the hazards involved are believed to be
predictable. Physicians should cease any investigation if the hazards are found to
outweigh the potential benefits.
8. In publication of the results of his or her research, the physician is obliged to
preserve the accuracy of the results. Reports of experimentation not in
accordance with the principles laid down in this Declaration should not be
accepted for publication.
9. In any research on human beings, each potential subject must be adequately
informed of the aims, methods, anticipated benefits and potential hazards of the
study and the discomfort it may entail.
250
10. He or she should be informed that he or she is at liberty to abstain from
participation in the study and that he or she is free to withdraw his or her consent
to participation at any time. The physician should then obtain the subject's freely-
given informed consent, preferably in writing.
11.When obtaining informed consent for the research project the physician should
be particularly cautious if the subject is in a dependent relationship to him or her
or may consent under duress. In that case the informed consent should be
obtained by a physician who is not engaged in the investigation and who is
completely independent of this official relationship.
12. In case of legal incompetence, informed consent should be obtained from the
legal guardian in accordance with national legislation. Where physical or mental
incapacity makes it impossible to obtain informed consent, or when the subject is
a minor, permission from the responsible relative replaces that of the subject in
accordance with national legislation. Whenever the minor child is in fact able to
give a consent, the minor's consent must be obtained in addition to the consent of
the minor's legal guardian.
13. The research protocol should always contain a statement of the ethical
considerations involved and should indicate that the principles enunciated in the
present Declaration are complied with.
II. MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
(Clinical Research)
1. In the treatment of the sick person, the physician must be free to use a new
diagnostic and therapeutic measure, if in his or her judgement it offers hope of
saving life, reestablishing health or alleviating suffering.
2. The potential benefits, hazards and discomfort of a new method should be
weighed against the advantage of the best current diagnostic and therapeutic
methods.
251
3. In any medical study, every patient - including those of a control group, if any -
should be assured of the best proven diagnostic and therapeutic method. This
does not exclude the use of inert placebo in studies where no proven diagnostic
or therapeutic method exists.
4. The refusal of the patient to participate in a study must never interfere with the
physician-patient relationship.
5. If the physician considers it essential not to obtain informed consent, the specific
reasons for this proposal should be stated in the experimental protocol for
transmission to the independent committee (I, 2).
6. The physician can combine medical research with professional care, the objective
being the acquisition of new medical knowledge, only to the extent that medical
research is justified by its potential diagnostic or therapeutic value for the patient.
Ill. NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN
SUBJECTS (Non-Clinical Biomedical Research)
1. In the purely scientific application of medical research carried out on a human
being, it is the duty of the physician to remain the protector of the life and health
of that person on whom biomedical research is being carried out.
2. The subjects should be volunteers - either healthy persons, or patients for whom
the experimental design is not related to the patient's illness.
3. The investigator or the investigating team should discontinue the research if in
his/her or their judgement it may, if continued, be harmful to the individual.
4. In research on man, the interests of science and society should never take
precedence over considerations related to the wellbeing of the subject.
252
ApPENID~X 71
Risk Assessment Scales
253
THE WATERLOW RISK ASSESSMENT CARD
A etite
Average o o
Above average 1 1
Obese 2 2
Below avera e 3 3
Complete/Catheterised Male
Occasional incontinence Female
Catheter/Incontinent of faeces 14-49
Double incontinence 50-64
65-74
75-80
81- lus
MgbOit" Specialrisks "
j,Tis$ue malnutrition "0i~~;;~"~~~~~4
Full e.g. Terminal cachexia
Restlesslfidgety Cardiac failure
Apathetic Peripheral vascular disease
Restricted Anaemic
Inertltraction Smoking
Chairbound
e.g. Diabetes, cerebrovascular accident
Motor/Sensory paraplegic 4-6
Cytotoxics
High dose steroids 4
Anti-inflammato
Score: 10+ At risk
15+ High risk
20+ Ve hi h risk
Source: Birchall, 1993:36.
254
THE DOUGLAS PRESSURE SORE CALCULATOR
Nutritional sfatus/Hb Pain
Well-balanced diet 4 Pain-free 4
Inadequate diet 3 Fear of pain 3
Fluids only 2 Periodic 2
Peripheral/parenteral feed 1 Pain on movement 1
Low haemoglobin 1 Continual discomfort 0
Ac;tivity .' Skiil state .. ,
Fully mobile 4 Intact 4
Walks with difficulty 3 Dry/red/th in 3
Chairbound 2 Superficial breaks 2
Bedfast 1 Full tissue thickness or cavity 1
.-
"Incontinence .' . MentëJh$t~te -: , ' , .i••
Continent 4 Alert 4
Occasionally 3 Apathetic 3
Urine 2 Stuporous/sedated 2
Doubly 1 Unco-operative 1
Comatose 0
Sp~~iéll,ri$kfactors " , ~~<> - <, ,.' :. iC.. ".
Deduct 2 for each factor: -
- Steroid therapy
- Diabetes
- Cytotoxic therapy
- Dyspnoea
Total score of 18 or below = at risk
Source: Birchall, 1993:37.
255
THE NORTON SCORE
A score of 14 or below = at risk
Physical condition -, Score
Good 4
Fair 3
Poor 2
Very bad 1
! M~ntal condition .'.
Alert 4
Apathetic 3
Confused 2
Stuporous 1
A'ct{vity .'.' .' •'. 't .:
Ambulant 4
Walk with help 3
Chair-bound 2
Bedfast 1
Mpi)i1ity .j;','.;., " <i .. } .......
Full 4
Slightly limited 3
Very limited 2
Immobile 1
'In~Qimt1ená{ ,.:, '., , ··>,r:'" " , , , .- "'j',, if' , .,"iX,
Not 4
Occasionally 3
Usually urine 2
Doubly 1
Source: Birchall, 1993:35.
256
THE GOSNELL SCALE
.. GOSNELL SCALE
PRESSURE SORE RISK ASSESSMENT
LD . Medical diagnosis:
Age: Sex: . Primary: .
Height: Weight: .. Secondary: .
Date of admission: . Nursing diagnosis: ..
Date of discharge: ..
Instructions: Complete all categories within 24 hours of admission and every other day thereafter.
Mental status Continence Mobility Activity Nutrition
1. Alert 1. Fully 1. Full 1. Ambulatory 1. Good
2. Apathetic controlled 2. Slightly 2. Walks with 2. Fair
3. Confused 2. Usually limited assistance 3. Poor
4. Stuporous controlled 3. Very limited 3. Chairfast
5. Unconscious 3. Minimally 4. Immobile 4. Bedfast
controlled
4. Absence of
control
TOTAL SCORE:
The higher the score, the higher the patient's risk status.
Source: Flanagan, 1997: 161.
257
PRESSURE SORE PREDICTION SCALE
PS PS
PRESSURE SORE PRESSURE SORE
PREVENTION AID PREDICTION SCORE
(1988)
No No Yes Yes
but but
Sitting up? (long time) 0 1 2 3
Unconscious? 0 1 2 3
Poor general condition? 0 1 2 3
Incontinent? 0 1 2 3
YES Yes NO
& No Total Score:
Lifts up? 0 1 2
Gets up and walks? 0 1 2
A total of 6 or more = danger
For precise answers see 'Category Examples' below:
Sitting up
Propped up in bed for long periods means a definite 'Yes' answer. Sitting in a chair can be as
risky, but wheelchairs are not quite as bad as ordinary chairs - for long periods. On admission
decide nursing position to be used.
Unconscious?
Mental confusion may qualify as a 'No but" answer,
Poor general condition?
This may be a sudden/severe illness, or a langstanding disability (for example paralysis); lack of
response to pain suggests a poor condition, as also does great age.
Incontinent?
The main point is how often the patient is wet underneath; although poor bladder/bowel control
may also mean that the skin is not healthy. On admission discover if patient was incontinent in
the last two days.
Lifts up?
When possible the patient is asked to try, without help from anyone else, to 'Lift up'. A 'Yes"
answer means that the patient does lift his pelvis clear of the bed (or seat) at the time of asking.
Gets up and walks?
A 'Yes" answer implies normal or nearly normal walking.
Source: Birchall, 1993:37.
258
ApPEN[)~X8
259
SKIN CARE AND EARLY TREATMENT
The Agency for Health Care Policy and Research (AHCPR) in the United States
employed an explicit, science-based methodology along with expert clinical
judgement to develop these specific statements and recommendations on
maintaining and improving tissue tolerance to pressure in order to prevent injury.
Extensive literature searches were conducted and critical reviews and syntheses
were used to evaluate empirical evidence and significant outcomes. Peer review and
pilot review were undertaken to evaluate the validity, reliability and utility of these
guidelines in clinical practice.
Goal: Maintain and improve tissue tolerance in order to prevent injury.
1. All individuals at risk should have a systematic skin inspection at least once a
day, paying particular attention to the bony prominences. Results of skin
inspection should be documented.
2. Skin should be cleansed at the time of soiling and at routine intervals. The
frequency of skin cleansing should be individualized according to the need and/or
patient preference. Avoid hot water, and use a mild cleansing agent that
minimizes irritation and dryness of the skin. During the cleansing process, care
should be used to minimize the force and friction applied to the skin.
3. Minimize environmental factors leading to skin drying, such as low humidity (less
than 40 percent) and exposure to cold. Dry skin should be treated with
moisturizers.
4. Avoid massage over bony prominences. Current evidence suggests that
massage over bony prominences may be harmful.
5. Minimize skin exposure to moisture due to incontinence, perspiration, or wound
drainage. When these sources of moisture cannot be controlled, underpads or
briefs can be used that are made of materials that absorb moisture and present a
quick-drying surface to the skin. Topical agents that act as barriers to moisture
can also be used.
260
6. Skin injury due to friction and shear forces should be minimized through proper
positioning, transferring, and turning techniques. In addition, friction injuries may
be reduced by the use of lubricants (such as corn starch and creams), protective
films (such as transparent film dressings and skin sealants), protective dressings
(such as hydrocolloids) and protective padding.
7. When apparently well nourished individuals develop an inadequate dietary intake
of protein or calories, caregivers should first attempt to discover the factors
compromising intake and offer support with eating. Other nutritional supplements
or support may be needed. If dietary intake remains inadequate and if consistent
with overall goals of therapy, more aggressive nutritional intervention such as
enteral or parenteral feedings should be considered. For nutritionally
compromised individuals, a plan of nutritional support and/or supplementation
should be implemented that meets individual needs and is consistent with the
overall goals of therapy.
8. If the potential exists for improving the individual's mobility and activity status,
rehabilitation efforts should be instituted if consistent with overall goals of therapy.
Maintaining current activity level, mobility, and range of motion is an appropriate
goal of most individuals.
9. Interventions and outcomes should be monitored and documented.
Source:
BERGSTROM, N., ALLMAN, R. M., CARLSON, C. E., EAGLSTEIN, w., FRANTZ, R.
A., GARBER, S. L., GOSNELL, D., JACKSON, B. S., KEMP, M. G., KROUSKOP, T.
A., MARVEL, E., RODEHEAVER, G. T. & XAKELLlS, G. C.1992. Pressure Ulcers in
Adults: Prediction and Prevention. Clinical practice Guideline. Quick Reference
Guide for Clinicians, No. 3. Rockville, MD: U. S. Department of Health and Human
Services, Public Health Service, Agency for Health Care Policy and Research.
AHCPR Publication No. 92-0050. May 1992.
261
MECHANICAL LOADING AND SUPPORT SURFACES
The Agency for Health Care Policy and Research (AHCPR) in the United States
employed an explicit, science-based methodology along with expert clinical
judgement to develop these specific statements and recommendations on the
protection against the adverse effects of pressure, shear and friction. Extensive
literature searches were conducted and critical reviews and syntheses were used to
evaluate empirical evidence and significant outcomes. Peer review and pilot review
were undertaken to evaluate the validity, reliability and utility of these guidelin~s in
clinical practice.
Goal: Protect against the adverse effects of external mechanical forces: pressure,
friction and shear.
1. Any individual in bed who is assessed to be at risk for developing pressure
sores should be repositioned at least every two hours if consistent with overall
patient goals. A written schedule for systematically turning and repositioning
the individual should be used.
2. For individuals in bed, positioning devices such as pillows or foam wedges
should be used to keep bony prominences (such as knees or ankles) from
direct contact with one another, according to a written plan.
3. Individuals in bed who are completely immobile should have a care plan that
includes the use of devices that totally relieve pressure on the heels, most
commonly by raising the heels off the bed. Do not use doughnut-type devices.
4. When the side-lying position is used in bed, avoid positioning directly on the
trochanter.
5. Maintain the head of the bed at the lowest degree of elevation consistent with
medical conditions and other restrictions. Limit the amount of time the head of
the bed is elevated.
6. Use lifting devices such trapeze or bed linen to move (rather than drag)
individuals in bed who cannot assist during transfers and position changes.
262
7. Any individual assessed to be at risk for developing pressure sores should be
placed when lying in bed on a pressure-reducing device, such as foam, static
air, alternating air, gel, or water mattress.
8. Any person at risk for developing a pressure sore should avoid uninterrupted
sitting in any chair or wheelchair. The individual should be repositioned,
shifting the point under pressure at least every hour or be put back to bed if
consistent with overall patient management goals. Individuals who are able
should be taught to shift weight every 15 minutes.
9. For chair-bound individuals, the use of pressure reducing devices such as
those made of foam, gel, air, or a combination is indicated. Do not use
doughnut-type devices.
10. Positioning of chair-bound individuals should include considerations of
postural alignment, distribution of weight, balance and stability, and pressure
relief.
11. A written plan for the use of positioning devices and schedules may be helpful
for chair-bound individuals.
Source:
BERGSTROM, N., ALLMAN, R. M., CARLSON, C. E., EAGLSTEIN, w., FRANTZ, R.
A., GARBER, S. L., GOSNELL, D., JACKSON, B. S., KEMP, M. G., KROUSKOP, T.
A., MARVEL, E., RODEHEAVER, G. T. & XAKELLlS, G. C.1992. Pressure Ulcers in
Adults: Prediction and Prevention. Clinical practice Guideline. Quick Reference
Guide for Clinicians, No. 3. Rockville, MD: U. S. Department of Health and Human
Services, Public Health Service, Agency for Health Care Policy and Research.
AHCPR Publication No. 92-0050. May 1992.
263
INFECTION CONTROL DURING THE MANAGEMENT OF PRESSURE SORES
The Agency for Health Care Policy and Research (AHCPR) in the United States
employed an explicit, science-based methodology along with expert clinical
judgement to develop these specific statements and recommendations on the
prevention of cross-contamination of pathological organisms during the management
of pressure sores. Extensive literature searches were conducted and critical reviews
and syntheses were used to evaluate empirical evidence and significant outcomes.
Peer review and pilot review were undertaken to evaluate the validity, reliability and
utility of these guidelines in clinical practice.
Body substance isolation
Follow body substance isolation (BSI) precautions or an equivalent system
appropriate for the health care setting and the patient's condition when treating the
pressure sores.
Clean gloves
Use clean gloves for each patient. When treating multiple sores on the same patient,
attend to the most contaminated sore last. Remove gloves and wash hands between
patients.
Sterile instruments for debridement.
Use sterile instruments to debride pressure sores. Following debridement, monitor for
the patient's temperature and be alert for signs of bacteraemia or sepsis.
264
Dressings
Use sterile dressings. Clean dressings may also be used in the home setting.
Disposal of contaminated dressings should be done in a manner consistent with local
regulations.
Keep dressings clean
Procedures to keep dressings clean and prevent cross-contamination should be
established and rigorously adhered to. These procedures include the following:
1. Strict adherence to BSI and good handwashing between patients.
2. Individual patients should have their own dressing supplies that are protected
from inadvertent environmental contamination by water damage, dust
accumulation, extreme temperatures, or contact contaminants.
3. Dressings should be kept in the original package or in other plastic packaging.
They should be stored in a clean dry place and the entire package should be
discarded if any dressings become wet, contaminated or dirty.
4. Caregivers must wash their hands before contact with the supply of clean
dressings or dressing supplies. Prior to the dressing or treatment, only the
number of dressings necessary for each dressing change should be removed
from containers. Once the hands of the caregiver are soiled with wound
secretions, they should not come into contact with the remaining clean dressings
or other supplies until the gloves are removed and hands are washed. Dressings,
instruments and solutions should be obtained from suppliers who can ensure that
shipment and handling will not expose the dressings and supplies to damage or
contamination.
Disposal
Local regulations vary on the disposal of soiled dressings.
265
Source:
BERGSTROM, N., ALLMAN, R. M., CARLSON, C. E., EAGLSTEIN, w. FRANTZ, R.
A., GARBER, S. L., GOSNELL, D., JACKSON, B. S., KEMP, M. G., KROUSKOP, T.
A., MARVEL, E., RODEHEAVER, G. T. & XAKELLlS, G. C.1992. Pressure Ulcers in
Adults: Prediction and Prevention. Clinical practice Guideline. Quick Reference
Guide for Clinicians, No. 3. Rockville, MD: U. S. Department of Health and Human
Services, Public Health Service, Agency for Health Care Policy and Research.
AHCPR Publication No. 92-0050. May 1992.
266
ApPEND~X9
Oost Analysis
267
1 Cost analysis
As mentioned in the methodology the cost analysis was performed from the
perspective of a private wound care practitioner. The cost of each dressing
change per patient per group that completed the study was calculated.
Completion implies either healed or completed the six-week treatment
period as specified in chapter 6.
The following were considered in calculating the cost of treatment:
o wound care products and
o wound care tariffs.
1.1 Wound care products
The cost of all the products used in the experimental group was obtained from
suppliers of Smith & Nephew ™ products in the Bloemfontein area. These
products and their prices are listed in table 1 below and reflect the retail price
that the patient will pay for each item when purchased through an
independent wound care practitioner.
TABLE 1: Price list of products used in the experimental group
Product Retail price
(Cost price + 10%)
OFS Dressing tray R 7.40
Allevyn™ non-adh. 20em x 20em R 141.99
Allevyn™ adh. 75mm x 75mm R 27.14
Allevyn™ adh. 12,5cm x 12,5em R 41.36
IntraSite™ Gel15g R 29.05
Opsite TM 10em x 12em R 9.48
Table 2 below reflects the products used by patients in the control group as
encountered by the researcher in the community. In order to arrive at a
reasonable cost for these items the researcher obtained the cost for each item
from six different suppliers in the Bloemfontein area and calculated an
average cost per item.
268
TABLE 2: Price list of products used in the control group
Product Price
Sterile latex gloves (pair) R 3.00
Gauze 75mm x 75mm (pack of 100) R13.48
Milton™ (500ml) R 13.40
Acriflavin (1OOml) R 5.67
Micropore™ tape (48mm x 3m) R 20.76
Bactrazine™ (50g) R 57.36
Tea tree oil (10ml) R 20.30
Flagyl™ (200mg tablets) x 20 R 24.45
Aqueous cream (500g) R 8.49
Betadine TM (25g) R 18-10
Coloplast™ ulcer dressing (10 x 10cm) R 23.65
Coloplast™ transparent dressing (9 x 4cm) R 24.70
Bactigrass™ (100mm x 100mm) R 29.08
Jelonet™ (95mm x 95mm) R 47.95
3M™ Island dressing (9 x 15cm) R 14.15
3M Transparent dressing R 16.77
Cotton wool R 9.10
Johnson & Johnson Nu-gel™ hydrogel (15g) R 62.06
Aserbine™ cream (50g) R 39.37
Saline as wound cleanser, was excluded from the cost analysis in both groups
since saline can be made by patients and their caregivers in the community
setting at a minimal cost (see Section 4.5.2.1 rh]). However, for the sake of
convenience pre-packed saline containers (Adcock Ingram's 30 ml. Sab-
Saline™ampules) were used in the experimental group. Similarly the cost of a
gentle soap to clean the peri-wound area in both groups was excluded in the
cost analysis since most patients already used this or a similar item.
269
However, in order to avoid the introduction of a possible extraneous variable
the researcher used the same brand of soap (Protex™ factor 1) to cleanse the
peri-wound areas of all wounds in both groups.
1.2 Wound care tariffs
The severity (stage) of the pressure sore and time required to treat the
specific wound determined the wound care tariff (See table 3). The following
tariffs, as published by the Board of Health Care Funders of Southern Africa
(2000), were used in the calculation of the treatment cost.
TABLE 3: Wound care tariffs
Tariff Pressure sore stage
R 41.40 (a simple wound) Stage 2
R 51.70 (a moderate wound) Stage 3
R 58.60 (an extensive wound) Stage 4
2 Total costs of wound treatment per group
Accurate record was kept of all dressing changes and products used by
means of the instruments (see Weekly Wound Assessment and Record of
Dressing Changes and Products Used in Appendix 3). Using the price lists
above the researcher was able to calculate the treatment costs. Table 4 below
indicates the total treatment cost of each patient in both groups that
completed the study. This includes the healers and non-healers.
270
TABLE 4: Treatment costs of healers and non-healers
Experimental group Control group
ne=23 .-.- _.'_ ._-n--"c-=-1-8_._-------
Patient Amount Patient Amount
03 non-healer R 2128.17 04 non-healer R 2 532.52
06 non-healer R 1 793.58 07 non-healer R 2 302.60
09 healer R 753.84 19 healer R1177.96
12 non-healer R 1 039.94 20 non-healer R 2 284.53
13 non-healer R 1 499.84 24 healer R 911.56
16 non-healer R 2 851.85 29 non-healer R 1 209.49
18 healer R 677.19 32 non-healer R 2 525.26
22 healer R 847.44 38 non-healer R 2 073.42
23 healer R 677.39 40 healer R 82.58
26 healer R 428.32 44 healer R 864.50
27 healer R 379.52 45 healer R 228.44
30 healer R 375.11 48 healer R 773.25
34 healer R 58.28 49 healer R 902.15
35 non-healer R 1 332.84 52 non-healer R 441.67
41 healer R 210.61 53 healer R 269.20
42 non-healer R 4 373.49 54 non-healer R 2 754.02
43 healer R 268.89 57 healer R 491.20
46 healer R214.16 60 non-healer R 1 000.36
47 healer R 356.22
-.--' ......._--,._.__._--___ _ -,-_._---,--_.. ----
50 healer R 542.97 ... I·'· '........ ,....
55 non-healer R 864.39
---.---------_ ..- ._---_._._._---_ ........
58 healer R 1 102.55
1--.
62 healer R 275.43
/
271
3. Examples of cost calculation
The following are examples of how the cost of treatment for each patient was
calculated.
Patient: 03 (Experimental group)
Allevyn™ non-adh. 20cm x 20cm @ R 141.99 x 5 R 709.95
IntraSite™ Gel15g @ R 29.05 x 2 R 58.10
Opsite TM 10cm x 12cm @R9.48x19 R 180.12
OFS Dressing tray @ R 7.40 x 9 R 66.60
Stage 4 Tariff @ R 58.60 x 19 dressing changes R 1 113.40
TOTAL: R 2128.17
Patient: 04 (Control group)
Milton 1 litre @ R 26.80 x 1 R 26.80
Gloves @ R 3.00 x 37 R 111.00
Flagyl™ (200mg tablets) x 20 @ R 24.45 x 2 R 48.90
Acriflavin (100ml) @ R 5.67 R 5.67
Gauze 75mm x 75mm (pack of @R13.48x3 R 40.44
100)
Micropore™ tape (48mm x 3m) @R20.76x4 R 83.04
Aserbine™ cream (50g) @ R 39.37 x 1 R 39.37
Cotton wool @R9.10x1 R 9.10
Stage 4 Tariff @ R 58.60 x 37 dressing changes R 2 168.20
TOTAL: R 2532.52
272
ApPENlI)~X 1(0
Ethlcs Oommrttee Approval
273
c::::=====TH;:;:::E=U=N=IV=E=R;;:;::S;:;:::ITY=O;:;:::F=TH::::E::::::::=;;0u;::R:=!A:::::N;:;:::G;:;:::E;:;:::F;:;:::R;:;:::E;:;:::E=S::::T:::::A;:;:::T;:;:::E=-=S-
Office of the Director: Administration ~
Faculty of Medicine
II;:! 339 BLOEMFONTEIN 9300 REPUBLIC OF SOUTH AFRICA
'it (051) 40S·301a14012S47 TElEFAX: (051) 4480-9&7 SA
ënquirh .•,Nlrs Niemand Tel4053004 ze" July 1998
MR N SMALL
SCHOOL OF NURSING
UOFS
Dear Mr Small
ETOVS NR: 142/98
RESEARCHER: MR N SMALL
PROJECT TITEL: CHRONIC WOUNDS IN THE COMMUNITY: A COMPARATIVE
ANALYSIS OF PRESSURE SORE TREATMENT MODALITlES.
During their meeting held on the 28t~ July 1998 the Ethics Committee approved the
abovementioned project. With regard to the advertisement the Committee requested that
il clearly be stated that participating in this research project will be in co-operation with the
medical practitioner of the trial person.
Your attention is kindly drawn to the requirement that a progress report be presented nol
later than one year after approval of the project.
Woutd you please quote the Etovs number as indicated above in subsequent
correspondence, reports and enquiries.
Yours faithfully
L
DIRECTOR: MEDICINE ADMINISTRATION
Ihs
274
REFERENCES
275
AGENCY FOR HEALTH CARE POLICY AND RESEARCH (AHCPR). 1994.
Clinical Practice Guideline. Pressure Ulcers in Adults: Prediction and
Prevention. U.S. Department of Health and Human Services. AHCPR
Publication No. 92-0050.
AllMAN, R. M., LAPRADE, C. A., NOEL, L. B., WALKER, J. M., MOORER,
C. A., DEAR, M. R. & SMITH, C. R. 1986. Pressure sores among hospitalized
patients. Annals of Internal Medicine. 105(3): 337-342.
ANDERSON, K. N. & ANDERSON, L. E. 1990. Mosby's Pocket Dictionary of
Medicine, Nursing, & Allied Health. St. Louis: The C. V. Mosby Company.
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