Proof of Concept study for a dressing glove
Research type
Research Study
Full title
Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE project): Proof of Concept study for a dressing glove
IRAS ID
213515
Contact name
Patricia Grocott
Contact email
Sponsor organisation
Research Management & Innovation directorate, King's College London
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Summary of Research
Epidermolysis Bullosa (EB) is a group of genetic conditions causing extensive, painful skin blisters and wounds. Four main types of EB are recognised, which all affect the hands but those patients usually requiring hand therapy interventions have Recessive Dystrophic EB (RDEB).
The proof of concept study is part of the GLOVE (Generation and evaLuation Of hand therapy deVices for Epidermolysis bullosa) project. The project aims (i) to develop two hand therapy devices; a disposable dressing glove and splint glove to manage blisters, wounds and contractures that occur on the hands of people with RDEB (ii) to design and implement the Hand Therapy Online (HTO) electronic patient record system and (iii) to determine the cost effectiveness of the devices and the HTO system.
The proof of concept study focuses on testing the clinical performance and cost effectiveness of the dressing glove when compared with conventional dressings.
Recruited GLOVE participants will be invited to participate in the 14 week study, conducted using a quasi-experimental, n-of-1 research design. Patients who have not participated in GLOVE will also be invited to join.
Participants will be asked to follow their usual dressing regime for six weeks. At week 7, they will be given several pairs of dressing gloves to replace their usual dressings, or starting to wear the glove if they avoid dressings normally and familiarise themselves. If participants usually wear their gloves to maintain their web spaces, they will wear these on top of the dressing glove to help assess compatibility.
Participants will provide feedback twice a week from week 7 on the dressing glove by answering 12 questions (TELER indicators) validated in the Pilot study (REC no: 16/LO/1046) using the HTO system.
Data from the HTO system will be used by the Health Economist to determine the dressing glove and HTO’s cost effectiveness.Summary of Results
We applied a participatory model to co-design patient-recorded outcome indicators for treatment evaluation of hand therapy devices in EB. The indicators were used to proof-of-concept test an innovative disposable dressing glove as an alternative to dressings and bandages. The study provided preliminary clinical evidence of device performance compared to conventional dressings. For participants who completed the study, clinical outcomes and experiences when wearing the dressing glove mostly improved or were maintained.
The proof-of-concept study provides evidence of how and why the dressing gloves performed, compared to using conventional dressings. Of the participants who completed the study, the indicators show improved experiences and appearance of the skin. These participants were able to wear the dressing glove. Most participants who tested the gloves, but did not complete the study, had advanced hand deformities. This made it difficult to manufacture a glove that fitted the hand well. Wound care in EB is complex and changing dressing practice takes, time, patience, and the support of the clinical team. Despite finding conventional dressings and bandages onerous to apply and wear, they are familiar. The children were used to wearing strips of dressing material between their web spaces. The dressing glove was an unknown and for these participants putting the glove on their hands was difficult.
Improvements in hand skin condition with the dressing glove may be attributable to increased dressing change frequency and the use of an innovative, breathable fabric, which wicks heat and moisture associated with skin maceration and blistering in EB. Participants reported reduced restriction of movement with the dressing gloves. A reduction in dressing materials also created an environment for the skin that is less prone to maceration. Improvements in the experience of wearing and changing dressings may also explain the increase in the frequency and reduced time for hand dressing changes. The latter is noted as a desirable patient-focussed outcome in a recent expert review of clinical research on wound healing in EB.
The increased frequency of dressing changes increased costs for two participants. However, the associated improvements in skin condition may result in delayed disease progression and reduced interventions (e.g., surgery) over a longer period. Previous studies have focused on the cost of wound care for the entire body noting high costs in a small population. This is the first study investigating the costs of EB hand wound care. These results provide early proof-of-concept for the disposable dressing glove for RDEB patients who could wear gloves. The participating NHS Trusts are maintaining bespoke supplies of the dressing glove. Further refinements addressing absorption and protection are being investigated in a further study.REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0420
Date of REC Opinion
30 Mar 2017
REC opinion
Favourable Opinion