Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is the source of local and/or systemic infection or sepsis. The local inflammation and infection destroy healthy surrounding tissues and extends the original damage. In order to prevent these complications, and in order to minimize the risk of infection, it is imperative to evaluate the burn and remove all of the offending eschar at the earliest possible opportunity. This removal of dead tissue is termed "debridement". The most direct debridement method for eschar removal is surgery. Traditional, conservative non-surgical debridement is a lengthy process which often involves many complications. The objective of this study is to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full thickness thermal burns and to compare DGD to standard of care (SOC).
Completed study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
Royal Hospital Perth
Perth, Western Australia, Australia
Pronto Socorro para Queimaduras de Goiania
Goiânia, Brazil
Hospital do Servidor Publico do Estado de Sao Paulo
São Paulo, Brazil
Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
Marseille, France
Center Des Brules Hopital Cochin
Paris, France
Unfallkrankenhaus Berlin Burn Center
Berlin, Germany
BG - Unfallklinik Ludwigshafen
Ludwigshafen, Germany
Klinikum Mannheim Universtatsklinikum
Mannheim, Germany
Soroka University Medical Center
Beersheba, Israel
Centro Grandi Ustionati
Cesena, Italy
...and 7 more locations
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Time frame: Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Co-primary: % treated wound autografted of deep partial wounds
Time frame: Post-debridement autografts
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
Time frame: As for primary endpoint
Time to complete wound closure
Time frame: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Timely eschar removal
Time frame: Debridement procedures
Blood loss
Time frame: Throughout study
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