This trial is now under way

Background Information

Roy Powell based at the Royal Devon & Exeter Hospital received approval for an application for a £250,000 award from the National Institute for Health Research under its Research for Patient Benefit programme that will feature our protective stockings in a trial.

Research Team

Dr. Roy Powell, Royal Devon & Exeter Hospital, Barrack Road, Exeter

Position held Research Design Consultant for RDS-SW, Royal Devon and Exeter Hospital, Exeter has been the main author of this application and of the research protocol.

He conducted the literature search (assisted by Exeter Medical Library staff), wrote the Background and Methods sections, drafted the lay summary, suggested the design for the study, prepared the Gantt chart, drafted the patient flow diagram and suggested some outcome measures, which are being assessed by service users. He also chaired meetings of the co-applicants and service users.

Dr Philip Evans, St Lukes Campus, Magdalen Road, Exeter

Position held GP and Director of the Primary Care Research Network (SW).

He will provide expert opinion on any health issues that arise concerning participants of the study. He will also bring a GP and primary care research perspective as well as advice on recruitment and retention from his PCRN(SW) role.

Dr Rohan Chauhan, Royal Devon & Exeter Hospital, Barrack Road, Exeter

Position held NHS Research Advisor/RDS Consultant and qualitative researcher.

He will conduct the interviews and analyse qualitative data arising from them

Dr. Carolyn Charman Royal Devon & Exeter Hospital, Barrack Road, Exeter

Position held Consultant Dermatologist.

She will provide expert opinion on any skin related problem that arises during the course of the trial.

Dr.  Colin Pritchard, Knowledge Spa, Royal Cornwall Hospitals Trust, Treliske Hospital, Truro

Position held RDS consultant and health economist.

He will provide support with summarising the health economics data. He wrote the health economics section and reviewed the whole study.

Mr Andrew Kingsley, Clinical Manager Infection Control & Tissue Viability for North, East and Mid Devon,  will provide expertise in tissue viability and knowledge of care homes in North Devon from recent research that he has conducted on wound prevalence there.

Ms Janine Prytherch (JP), Clinical Nurse Manager for Exeter Tissue Viability Service, will provide expert opinion on the treatment of any skin lacerations or other injuries sustained by participants during the course of the trial. She will also provide contacts with care homes in the Exeter and East Devon area.

Further contributions have been made by Dr Paul Ewings, Mr Andy Barton and Mrs Sue Anderson.

The proposal was also reviewed by the RDS South West scientific committee prior to submission.

Research 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.

Abstract

Many people develop thin or ‘fragile’ skin on their lower legs and forearms. This is easily and seriously injured even after a minor knock. Fragile skin results from the ageing process but also the long-term use of steroids, sun exposure and skin diseases. The injuries, ‘skin tears’ can cover a wide area. Urgent professional attention is required; the injury is very painful and can take a long time to heal. There is also a risk that the injury will develop into a leg ulcer. An ulcer takes a very long time to heal and requires professional help, and in some cases daily attention.

Surveys of residents of care homes show that the number of skin tears a resident receives can be as many as five in a year. People who suffer most from fragile skin are over 70, the UK population in this age-group in 2011 is greater than 7 million. We estimate that at least 3 million people may suffer these very unpleasant and confidence sapping injuries, which result in very high treatment costs for the NHS.

Protective knee-length stockings have now been developed to prevent skin tears to the lower leg. A recent evaluation involving 20 patients in 8 private nursing homes for up to 10 weeks showed greatly reduced rates of trauma than would be expected (one small 7mm skin tear). In this proposed pilot study, we will invite 90 residents of private nursing homes to participate and be divided into 2 groups at random. One group will wear new protective stockings and the other group will wear usual clothing for 16 weeks. All injuries will be recorded in both groups and experiences of using the stockings will be discussed with the wearers. This proposed pilot study will be followed by a larger controlled trial of effectiveness.