Proof of Concept Study for a Dressing Glove

NCT03241628 | Completed

• 1 other identifier: 17/LO/0420
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidermolysis Bullosa Dystrophica

Keywords

Skin blisters; Finger webbing; Finger contracture; Hand contracture

Outcome Measures

Primary Outcomes (1)

• Effectiveness of disposable dressing glove compared with normal dressings and bandages

  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.

  14 weeks

Secondary Outcomes (1)

• Compatibility with the SkinniesTM Web Spacer glove

  14 weeks

Other Outcomes (1)

• Device preference

  14 weeks

Study Arms (1)

Dressing Glove

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

Interventions

Dressing Glove DEVICE

Viscose dressing glove

Dressing Glove

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children with RDEB and hand deformaties

You may qualify if:

• Adults (over the age of seventeen) with RDEB who use or have used dressings and bandages on their hands.
• Parents/carers of adults over the age of 17 with RDEB who use or have used dressings and bandages on their hands.
• Parents/carers of babies, children and young people (up to the age of 17) with RDEB who use or have used dressings and bandages on their hands.
• Babies, children and young people (age 1-17 years) with RDEB who use or have used dressings and bandages on their hands.
• Able to communicate in English, verbally and in writing
• Able to make an informed decision to participate and to give written consent
• Not participating in concurrent clinical studies

You may not qualify if:

• Babies aged less than 1 year old
• Not able to communicate in English, verbally and in writing
• Not able to make an informed decision to participate and to give written consent
• Participating in concurrent clinical studies

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Cardiff University: collaborator
• University of Surrey: collaborator

Study Sites (1)

King's College London

London, SE1 8WA, United Kingdom

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica; Blister

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vesiculobullous; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Grocott, PhD

  NIHR i4i

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 7, 2017
• Study Start: May 3, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)