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An RCT to Determine an Effective Skin Regime Aimed at Improving Skin Barrier Function and Quality of Life in Those with Podoconiosis in Ethiopia

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An RCT to Determine an Effective Skin Regime Aimed at Improving Skin Barrier Function and Quality of Life in Those with Podoconiosis in Ethiopia THE UNIVERSITY OF HULL An RCT to determine an effective skin regime aimed at improving skin barrier function and quality of life in those with podoconiosis in Ethiopia being a Thesis submitted for the Degree of PhD in the University of Hull by Jill Brooks, M.Phil., BA (Hons), RGN, Dip Trop Nurs. 11th April 2016 CONTENTS ACKNOWLEDGEMENTS. 11 CHAPTER 1. INTRODUCTION. 13 1.1. SIGNIFICANCE OF THE STUDY. 13 1.2. ORGANISATION OF THE THESIS. 16 CHAPTER 2. LITERATURE REVIEW. 18 2.1. INTRODUCTION. 18 2.2. SKIN DISEASE IN RESOURCE-POOR COUNTRIES. 18 2.3. PODOCONIOSIS. 20 2.3.1. NATURE AND SIGNIFICANCE OF PODOCONIOSIS. 21 2.3.2. PREVALENCE OF PODOCONIOSIS. 23 2.3.2.1. PREVALENCE OF PODOCONIOSIS IN ETHIOPIA, PATIENT’S AGE AND GENDER. 24 2.3.3. DIAGNOSIS AND STAGES OF PODOCONIOSIS. 26 2.3.4. EFFECTS OF PODOCONIOSIS ON THE SKIN AND LYMPHATIC SYSTEM. 28 2.3.5. ACUTE ADENOLYMPHANGITIS IN PODOCONIOSIS. 36 2.3.6. ADENO-LYMPHANGITIS IN LYMPHATIC FILARIASIS. 37 2.3.7. PREVENTION AND MANAGEMENT OF PODOCONIOSIS. 38 2.3.8. EFFECT OF DIFFERENT CARE/MANAGEMENT SERVICES. 48 2.3.8.1. REASONS FOR NON-ATTENDANCE AT PODOCONIOSIS CLINICS. 49 2.3.9. ECONOMIC CONSEQUENCES OF SKIN DISEASE AND PODOCONIOSIS. 50 2.3.10. PATIENT’S KNOWLEDGE OF ADENOLYMPHANGITIS IN PODOCONIOSIS. 51 2.3.11. KNOWLEDGE AND ATTITUDES OF HEALTH EXTENSION WORKERS, PATIENTS AND THE COMMUNITY TOWARDS PODOCONIOSIS. 51 2.3.11.1. HEALTH EXTENSION WORKER’S KNOWLEDGE. 52 2.3.11.2. COMMUNITY KNOWLEDGE. 52 2.3.11.3. PATIENT’S KNOWLEDGE OF PODOCONIOSIS AND PREVENTION. 53 2.3.12. PSYCHO-SOCIAL IMPACT OF PODOCONIOSIS. 59 2.3.13. QUALITY OF LIFE OF THOSE WITH PODOCONIOSIS. 62 2.3.14. CHALLENGES OF PROVIDING SKIN CARE IN RESOURCE-POOR COUNTRIES. 64 2.3.15. CLEANING SKIN IN RESOURCE-POOR COUNTRIES. 64 2.3.15.1. ACCESSING SKIN CLEANSERS, DRYING CLOTHS AND EMOLLIENTS. 66 2.3.16. KEY GAPS IN KNOWLEDGE ON THE TREATMENT OF PODOCONIOSIS 66 2.3.17. SUMMARY OF SECTION 2.3. 67 1 2.4. ASSSESSMENT AND MEASUREMENT OF SKIN BARRIER FUNCTION. 69 2.4.1. THE IMPACT OF ETHNICITY ON SKIN BARRIER FUNCTION. 71 2.4.2. ETHNIC DIFFERENCES RELATED TO TRANS-EPIDERMAL WATER LOSS, STRATUM CORNEUM HYDRATION AND pH. 72 2.4.2.1. OTHER STUDIES OF ETHNICITY AND SKIN. 74 2.4.3. THE IMPACT OF GENDER DIFFERENCES ON SKIN BARRIER FUNCTION. 74 2.4.3.1. GENDER DIFFERENCES RELATED TO TRANS-EPIDERMAL WATER LOSS AND STRATUM CORNEUM HYDRATION. 74 2.4.4. THE EFFECT OF SKIN DISEASE ON BARRIER FUNCTION. 75 2.4.5. EFFECTS OF PSYCHOLOGICAL STRESS ON SKIN BARRIER FUNCTION. 77 2.5. THE PSYCHO-SOCIAL IMPACT OF SKIN DISEASE. 79 2.6. IMPROVING AND MAINTAINING HEALTHY SKIN BARRIER FUNCTION. 81 2.6.1. MAINTAINING OPTIMUM STRATUM CORNEUM HYDRATION AND TRANS- EPIDERMAL WATER LOSS. 82 2.6.1.1. WATER FOR CLEANING THE SKIN. 82 2.6.1.2. SOAP FOR CLEANING THE SKIN. 84 2.6.2.EFFECT ON SKIN OF THE COMBINATION OF DIFFERENT WASHING AND DRYING TECHNIQUES. 87 2.6.3. EFFECTS ON SKIN OF DIFFERENT DRYING PRACTICES. 87 2.6.4. EMOLLIENTS. 88 2.6.4.1. ‘LEAVE-ON’ EMOLLIENTS. 88 2.6.4.2. GLYCERINE. 89 2.6.4.3. FATS/OILS IN EMOLLIENTS. 92 2.6.4.4. POTENTIAL ALLERGENS AND SENSITIZERS IN EMOLLIENTS. 94 2.6.4.5. APPLYING EMOLLIENTS TO THE SKIN. 95 2.6.4.6. WHEN AND HOW TO APPLY AN EMOLLIENT. 95 2.6.4.7. HOW MUCH EMOLLIENT TO APPLY. 96 2.6.5. SUMMARY OF SECTION 2.6. 97 2.7. SUMMARY OF CHAPTER 2. 98 CHAPTER 3. PILOT STUDY 100 3.1 INTRODUCTION. 100 3.2. AIM AND OBJECTIVES OF THE PILOT STUDY. 101 3.3. METHOD 101 3.3.1 STUDY DESIGN 101 3.3.2. SAMPLE SIZE AND SELECTION 101 3.3.3. INCLUSION AND EXCLUSION CRITERIA. 102 3.3.4. TIME PERIOD. 102 2 3.3.5. PERMISSION AND ETHICAL APPROVAL. 102 3.3.6. INTERVENTIONS AND RATIONALE. 103 3.3.7. PREPARING PILOT INTERVENTIONS. 106 3.3.7.1. SOAPY WATER. 106 3.3.7.2. WATER. 106 3.3.7.3. GLYCERINE. 106 3.3.7.4. VASELINE® (PETROLEUM JELLY). 106 3.3.8. BODY SITES. 107 3.3.9. MEASUREMENTS OF SKIN BARRIER FUNCTION. 108 3.3.9.1. TRANS-EPIDERMAL WATER LOSS. 108 3.3.9.2. STRATUM CORNEUM HYDRATION. 108 3.3.10. INDEPENDENT AND DEPENDENT VARIABLES. 109 3.3.11. POSSIBLE ADVERSE EFFECTS OF THE PILOT STUDY. 109 3.4. DATA ANALYSIS OF PILOT STUDY. 109 3.4.1. STATISTICAL METHOD. 110 3.5. RESULTS. 110 3.5. DISCUSSION. 113 3.6. CONCLUSION. 114 CHAPTER 4. METHOD. 115 4.1. INTRODUCTION. 115 4.2. THE RESEARCH AIM, OBJECTIVES AND NULL HYPOTHESIS. 115 4.2.1. AIM. 115 4.2.2. OBJECTIVES. 115 4.2.3. NULL HYPOTHESIS. 116 4.3. RESEARCH DESIGN AND METHODOLOGY. 116 4.3.1. RESEARCH DESIGN. 116 4.3.1.1. VALIDITY AND RELIABILITY OF RESEARCH DESIGN. 117 4.3.1.2. ETHICAL APPROVAL. 117 4.3.1.3. STUDY POPULATION. 117 4.3.1.4. INCLUSION/EXCLUSION CRITERIA. 118 4.3.1.5. CONTROL GROUP. 118 4.3.1.6. EXPERIMENTAL GROUP. 119 4.3.1.7. SUSTAINABILITY OF PRODUCTS USED IN THE RESEARCH. 121 4.3.1.8. STUDY SAMPLE SIZE. 122 4.3.1.9. EDUCATIONAL PROGRAMME PROVIDED FOR Clinc STAFF. 123 4.3.2. RECRUITING PATIENTS ONTO THE STUDY. 123 3 4.3.2.1. PARTICIPANT CONSENT. 124 4.3.2.2. ALLOCATION TO GROUPS. 124 4.3.2.3. EDUCATION OF PARTICIPANTS. 124 4.3.2.4. FREQUENCY OF DATA COLLECTION AND STUDY PERIOD. 125 4.3.2.5. DATA RECORDED, RATIONALE AND METHOD. 125 4.3.2.6. MEASUREMENT SITES. 129 4.3.2.6.1. MoistureMeterSC® AND VapoMeter®. 129 4.3.2.6.2. PODOCONIOSIS STAGING TOOL. 130 4.4. TREATMENT FIDELITY. 131 4.5. DATA COLLECTION AND FOLLOW-UP CLINIC VISITS. 132 4.6. DATA ANALYSIS. 133 4.6.1. MEASURES OF THE RELATIONSHIP BETWEEN NUMBER OF WOUNDS AND NUMBER OF WORK DAYS LOST. 133 4.6.2. OUTCOME MEASURES OF TRANS-EPIDEMAL WATER LOSS, STRATUM CORNEUM HYDRATION, LEG AND FOOT CIRCUMFERENCE AND DERMATOLGY LIFE QUALITY INDEX. 134 4.6.3. OUTCOME MEASURES OF THE NUMBER OF WORK DAYS LOST DUE TO ADENOLYMPHANGITIS, STAGE OF PODOCONIOSIS, MOSSY CHANGES, LEG ODOUR AND THE NUMBER OF LOWER LEG/FOOT WOUNDS. 134 CHAPTER 5. RESULTS. 136 5.1. OVERVIEW OF RESULTS. 136 5.1.1. STRATIFICATION OF CLINIC, GENDER AND DISEASE SEVERITY . 136 5.2. DEMOGRAPHIC PROFILE OF PARTICIPANTS. 137 5.2.1. STUDY PARTICIPANTS. 137 5.2.2. AGE OF PARTICIPANTS. 138 5.2.3. GENDER OF PARTICIPANTS. 138 5.2.4. OCCUPATION OF PARTICIPANTS 139 5.2.5. TIME TO ONSET OF CLINICAL SIGNS OF PODOCONIOSIS. 139 5.2.6.TYPE OF SHOES WORN. 140 5.3. SKIN BARRIER FUNCTION. 142 5.3.1. TRANS-EPIDERMAL WATER LOSS. 142 5.3.1.1. MEAN TRANS-EPIDERMAL WATER LOSS AT SPECIFIC POINTS ON THE LEG/FOOT OF ALL PARTICIPANTS AT BASELINE. 143 5.3.1.2. TRANS-EPIDERMAL WATER LOSS AT TOP OF LOWER LEGS. 143 5.3.1.3. TRANS-EPIDERMAL WATER LOSS AT MID-POINT ON THE LOWER LEGS. 145 5.3.1.4. TRANS-EPIDERMAL WATER LOSS AT BASE OF LOWER LEGS. 147 5.3.1.5. TRANS-EPIDERMAL WATER LOSS ON THE TOP OF THE FOOT. 149 4 5.3.2. STRATUM CORNEUM HYDRATION. 151 5.3.2.1. MEAN SC HYDRATION AT DIFFERENT POINTS ON THE LEGS/FEET OF ALL PARTICIPANTS AT BASELINE. 151 5.3.2.2. STRATUM CORNEUM HYDRATION AT TOP OF LOWER LEGS. 151 5.3.2.3. STRATUM CORNEUM HYDRATION AT THE MID-POINT ON LOWER LEGS.154 5.3.2.4. STRATUM CORNEUM HYDRATION AT BASE OF LOWER LEGS. 156 5.3.2.5. STRATUM CORNEUM HYDRATION ON THE TOP OF FEET. 158 5.4. GENERAL CLINICAL PROFILE OF LEGS/FEET. 160 5.4.1. STAGE OF PODOCONIOSIS. 160 5.4.2. MOSSY SKIN CHANGES. 161 5.4.3. LEG/FOOT ODOUR. 161 5.4.4. NUMBER OF LEG/FOOT WOUNDS. 162 5.4.5. LOWER LEG CIRCUMFERENCE. 163 5.4.6. FOOT CIRCUMFERENCE. 165 5.4.7. NUMBER OF WORK DAYS LOST IN PREVIOUS MONTH DUE TO ADENOLYMPHANGITIS. 166 5.4.8. CORRELATION BETWEEN DAYS LOST DUE TO ADENOLYMPHANGITIS AND NUMBER OF WOUNDS. 170 5.5. QUALITY OF LIFE. 170 CHAPTER 6. DISCUSSION. 172 6.1. OVERVIEW OF RESULTS. 172 6.2. STUDY RESULTS. 173 6.2.1. SOCIAL AND DEMOGRAPHIC PROFILE OF PARTICIPANTS. 174 6.2.1.1. AGE OF PARTICIPANTS. 174 6.2.1.2. OCCUPATION AND GENDER OF PARTICIPANTS. 174 6.2.1.3. TIME FROM ONSET OF CLINICAL SIGNS OF PODOCONIOSIS TO CLINIC ATTENDANCE. 175 6.2.1.4. TYPE OF SHOES WORN. 177 6.2.2. SKIN BARRIER FUNCTION. 180 6.2.2.1. TRANS-EPIDERMAL WATER LOSS. 180 6.2.2.3. STRATUM CORNEUM HYDRATION. 182 6.2.3. GENERAL CLINICAL PROFILE OF LEGS/FEET. 185 6.2.3.1. STAGE OF PODOCONIOSIS. 185 6.2.3.2. MOSSY CHANGES. 185 6.2.3.3. THE NUMBER OF WOUNDS AND ODOUR ON THE LOWER LEGS/FEET. 186 6.2.3.4. DAYS OF WORK LOST DUE TO ADENOLYMPHANGITIS. 187 6.2.3.5. CORRELATION BETWEEN WORK DAYS LOST DUE TO ADENOLYMPHANGITIS, NUMBER OF WOUNDS AND STAGE OF PODOCONIOSIS. 188 5 6.2.3.6.
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