BEST SCAR 1
Research type
Research Study
Full title
A single blinded, randomised trial into the efficacy of silicone sheeting for cutaneous scars. The Best Evidence for Scar Treatment (BEST) 1 group trial.
IRAS ID
335814
Contact name
Alexandra Murray
Contact email
Sponsor organisation
Buckinghamshire Healthcare NHS Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The proposed trial will test the efficacy of an existing anti-scarring therapy. The treatment consists of a single-blinded, randomised controlled trial of a topical silicone sheeting, which has been adopted worldwide as a conventional treatment with very limited evidence for its benefit.
We anticipate that this study will generate the first evidence for the efficacy of this intervention using objective outcome measures. The null hypothesis is that topical silicone sheet does not improve clinical scarring in humans.
Healthy subjects who will take part in an intra-subject, intervention versus no intervention, blinded study. All patients will receive a standardized scratch injury to the skin of the lateral hip area under anaesthetic cream. This highly stereotyped model creates a small wound that heals quickly and then results in a couple of centimetres of scarring at 18 months after injury. After the acute phase of injury, the subjects will be randomised to apply topical silicone to one of the resulting scars as it matures. The application of the silicone will be according to standard clinical recommendations. The opposite side will have no intervention and will act as the control. The subjects will be followed up at two, three, six, 12 months and 18 months post-injury.
Scar assessment will take place with scar assessment scales (Modified Vancouver, POSAS) and objective outcome measures (laser Doppler imaging, high-frequency ultrasound for scar morphometry; and high-resolution photography).
The data gathered will only be unblinded for statistical analysis of efficacy once scar assessment is complete. Statistical analysis will be performed on the dataset.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0169
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion