Title: Randomised controlled trial of protective stockings against usual care to reduce skin tears and bruises in high risk elderly people living in care homes: a pilot study
Funder: Department of Health (England)

Abstract: BACKGROUND Fragile skin occurs primarily on the lower legs and forearms and is caused by: the natural ageing process, long term use of topical or oral steroids, chronic sun exposure and inflammatory skin disease. Minor impact with common objects causes major and intractable skin tears which need to be treated professionally and urgently. A skin tear is defined as a traumatic wound occurring principally on the extremities of older adults, as a result of friction alone or shearing and friction forces. They are very distressing for the patient and expensive for the NHS. Pre-pilot observation in private nursing homes has indicated that recently developed protective stockings could help prevent skin tears to the lower legs. AIMS This proposed pilot study is intended to pave the way for a definitive randomised controlled trial assessing the effectiveness and cost-effectiveness of the new stockings in protecting the lower legs. The aim of this pilot study is to provide the necessary information for the planning of the future trial. It will test the feasibility of running such a trial and provide estimates of: recruitment (homes and residents), trial attrition, completion of questionnaire-based quality of life measures, baseline scores and standard deviations of those measures in this population. It will test the feasibility of gathering data on skin tears occuring in the care homes by research nurses. It will assess the acceptability of using the protective stockings and also of participating in the trial. It will provide useful information about the distribution of the variables to inform the sample size calculation for a larger study. It will also provide an estimate of the impact of any contamination (during subsequent interviews). PLAN Care homes will be recruited via the Devon NHS Tissue Viability Service database. Eligible residents who have recovered from at least one skin tear and who live in approximately 30 homes in North & East Devon will be approached. 90 residents will be recruited and randomised into two groups stratified by care home. One group will wear the protective stockings on a daily basis during the waking day for a period of 16 weeks whilst the other group wear their usual clothing. Skin tears in both groups will be assessed and treated by care home nurses. They will record the date, time, size and category of skin tear, how caused, and assign it a severity score. A research nurse will visit the next day to inspect the wound and ensure it is photographed. Research nurses will also make weekly visits to check progress of the trial and transfer data from tissue viability charts to case report forms Experiences of using the stockings will be captured through semi-structured interviews with participants and carers and a focus group of professionals. POTENTIAL BENEFIT Published evidence indicates that in American care homes the prevalence of lacerations is between 1 and 6 per patient per year with those over 80 years being the most susceptible. In North Devon care homes, the point prevalence of wounds resulting from trauma was 4.77%. There are over 7 million people in the UK aged 70+ in 2010 and many of these will be at risk. This results in very considerable suffering, high cost to the NHS and loss of personal confidence due to fear of skin tears. One consequence of lacerations is the development of leg ulcers which cost the NHS Tissue Viability Services £1.2 billion pa to treat. If the eventual definitive trial is able to demonstrate effectivesness and cost-effectiveness, the new stockings could be made widely available thus reducing suffering, increasing quality of life and save the NHS money.


Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: SKIN