Debrase Scar Formation and Quality of Life Study
Research type
Research Study
Full title
Scar Formation and Quality of Life Assessment in Adults and Children Following Treatment with Debrase Compared to Standard of Care Treatment (Protocol MW2012-01-02)
IRAS ID
79766
Sponsor organisation
Mediwound Ltd
Eudract number
2011-001889-17
Clinicaltrials.gov Identifier
Research summary
Only decades ago, even small wounds were difficult to heal and in some cases were potentially lethal, so survival of burn victims was the main target of studies at that time. Today, however, subjects may survive even large wounds because of advances in shock therapy and infection prevention. Once the subject has survived the acute phase, the resulting scar becomes a major medical issue because of complications that may lead to cosmetic (how the scar appears) and functional (pain, effect on movement of limbs) effects. These functional and cosmetic outcomes have become as equally important as the actual wound closure in assessing the efficacy of wound healing products.Debrase is a new agent that quickly and selectively removes the dead tissue layer (eschar) from burns by enzymatic action without damaging healthy tissue. The clean skin bed can heal spontaneously or, if a full thickness burn has occurred, the resultant bed can serve as a recipient surface for skin grafting. Debrase is applied to the burn as a gel for a period of four hours. In most cases, Debrase is effective after a single application; however, it may be applied for a second time to the same burn area if medically required. In this follow-up study, the wounds of patients in the two treatment arms of the MW2004-11-02 study (Debrase and Standard of Care) will be compared in order to evaluate the possible long term flunce of the eschar removal technique on wound healing and scar formation, as well as comparing the quality of life of subjects in the Debrase and Standard of Care treatment groups.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
11/LO/0899
Date of REC Opinion
26 Jul 2011
REC opinion
Further Information Favourable Opinion