Feasibility study: ReCell spray used with meshed skin grafts
Research type
Research Study
Full title
A feasilbility study to investigate the benefits and costs of ReCell with meshed autografts versus autografts alone in burns
IRAS ID
229298
Contact name
Susan C Peirce
Contact email
Clinicaltrials.gov Identifier
16-AUG-6578, Cardiff and Vale Research Review Service (CaRRS)
Duration of Study in the UK
2 years, 3 months, 9 days
Research summary
People who have had a serious burn are often treated with a skin graft. A thin piece of skin is taken from an unburned area (donor site) and used to cover the burn wound. Sometimes the graft is ‘meshed’ and stretched so that a smaller amount of graft skin is needed. The wider the mesh, the bigger the holes, and the smaller the area of donor graft skin needed to cover the burn. The mesh pattern will be visible in the scar afterwards, but this fades over time.
ReCell is a medical device, used in the operating theatre, that processes a small sample of skin into a suspension of skin cells. This is put into a syringe with a spray nozzle and sprayed over the meshed graft and the donor sites. The aim is that the cells will fill in the holes, help the graft and donor site to heal faster, and improve the appearance of the resulting scars.
The National Institute of Health and Care Excellence (NICE) assessed ReCell in 2014 and decided there wasn’t enough evidence to say whether it should be used routinely in the NHS. This current study is testing the design and feasibility of a full-scale trial that would investigate the effectiveness of using ReCell with meshed grafts.
Adults with burns that cover 2%-60% of their body surface area and who need a meshed skin graft are eligible for this study. Participants will be treated in specialist burns services and will be randomly allocated to have standard treatment, or to have grafts that are more widely meshed plus ReCell spray. They will be followed up for a year. We will assess the practicalities of running a surgical trial in burns, and obtain estimates of important variables related to using the technology and to patient outcomes.REC name
Wales REC 4
REC reference
17/WA/0173
Date of REC Opinion
4 Jul 2017
REC opinion
Further Information Favourable Opinion