Proof of Concept Study for a Dressing Glove
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|ClinicalTrials.gov Identifier: NCT03241628|
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : February 15, 2018
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.
|Condition or disease||Intervention/treatment|
|Epidermolysis Bullosa Dystrophica||Device: Dressing Glove|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE Project): Proof of Concept Study for a Dressing Glove|
|Actual Study Start Date :||May 3, 2017|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Fitting bespoke dressing gloves (viscose Class 1 medical device) and evaluating dressing glove performance in the management of blisters using patient recorded outcome measures. The aim is to obtain proof of concept data for the dressing glove as an acceptable alternative to patch work dressings held in place with bandages.
The study protocol recommends a daily change of the dressing glove but the patients also contribute their preference for frequency of dressing changes.
Device: Dressing Glove
Viscose dressing glove
- Effectiveness of disposable dressing glove compared with normal dressings and bandages [ Time Frame: 14 weeks ]Dressing glove performance against pre-determined performance criteria (12 patient recorded outcome measures on the HTO system) at the individual and group level with each participant acting as their own control.
- Compatibility with the SkinniesTM Web Spacer glove [ Time Frame: 14 weeks ]Determination of the compatibility of disposable dressing glove with the SkinniesTM Web Spacer glove or any other make of glove used by the participants with RDEB to maintain their web spaces
- Device preference [ Time Frame: 14 weeks ]Would they like to continue to wear the dressing glove
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241628
|King's College London|
|London, United Kingdom, SE1 8WA|
|Principal Investigator:||Patricia Grocott, PhD||NIHR i4i|