Suprathel(R) Effectivenss on Skin Graft Donor Sites in older patients
Research type
Research Study
Full title
A prospective randomised controlled trial comparing the effectiveness of Suprathel versus the standard of care dressing sterilised hyperfix for Split Thickness Skin Graft Donor Sites in older Patients
IRAS ID
258208
Contact name
David Barnes
Contact email
Sponsor organisation
Mid-Essex Hospital Services NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study compares the impact on wound healing, patient comfort and satisfaction between Suprathel dressing and the current standard of care sterilised Hyperfix dressing in older patients (above 65 years)undergoing split thickness skin grafts to close skin wounds following skin cancer surgery or burn injury. Specifically, we wish to evaluate the time to heal (primary outcome) and some secondary outcomes: pain associated, infection rates, patient and clinician satisfaction and the cost benefit of the new dressing.
Eligible patients will receive Suprathel or the current standard of care sterilized Hyperfix to their graft site wound. All 120 patients will be randomised (unblinded) alternately to receive either the Suprathel or sterilized Hyperfix dressing to their donor site as part of the study. Participants (as with normal clinical practice) will return to the treatment centre weekly for their graft site healing to be assessed. There will be no additional visits expected for any of the patients. Healing will be clinically determined once 95% re-epithelization occurs of the graft site skin has been accomplished.
There will be 60 participants in each group of 65 years or above (120 patients in total).REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0336
Date of REC Opinion
12 Jun 2020
REC opinion
Further Information Favourable Opinion