GellanAA
Research type
Research Study
Full title
An open, first-in-human, blind-evaluated, single centre, randomised, controlled, clinical Investigation to evaluate the safety and performance of GELLAN/Acetic Acid dressing in the treatment of burn wounds
IRAS ID
326659
Contact name
Naeim Moiemen
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
XX1007, CRCTU Reference Number
Duration of Study in the UK
1 years, 0 months, 6 days
Research summary
A new kind of gel-based dressing (Gellan) has Acetic Acid (AA) incorporated (antimicrobial) into the dressing to assist with healing and has anti-scarring properties to improve the healing of skin burns. The dressing can deliver a sustained dose of AA into the burn wound (over three days), therefore daily dressing changes are not required. The transparent and non-adhesive characteristics of the dressing means that it is possible to leave the wound undisturbed for a longer period of time, by allowing inspection through the transparent material. The non-adhesive nature of the dressing reduces the typical painful dressing removal, causing less distress to the patient. Incorporating AA into the Gellan gel dressing might boost its healing performance and reduce scarring even more than just the gel alone.
This clinical study will collect clinical data to demonstrate the safety and effectiveness of AA loaded Gellan gel dressings in burns. The study will also look at whether it improves the burn’s healing time and reduces scarring, when compared to the current Standard of Care dressing, Urgotul-silver.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0270
Date of REC Opinion
12 Feb 2024
REC opinion
Further Information Favourable Opinion