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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DGD | Experimental |
| |
| SOC | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DGD | Drug | Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds | 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 | Post-debridement autografts |
| Measure | Description | Time Frame |
|---|---|---|
| % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds | As for primary endpoint | |
| Time to complete wound closure | % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lior Rosenberg, MD | MediWound Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Hospital Perth | Perth | Western Australia | Australia | |||
| Pronto Socorro para Queimaduras de Goiania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15555800 | Background | Rosenberg L, Lapid O, Bogdanov-Berezovsky A, Glesinger R, Krieger Y, Silberstein E, Sagi A, Judkins K, Singer AJ. Safety and efficacy of a proteolytic enzyme for enzymatic burn debridement: a preliminary report. Burns. 2004 Dec;30(8):843-50. doi: 10.1016/j.burns.2004.04.010. | |
| 38837237 | Derived | Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Timely eschar removal | Debridement procedures |
| Blood loss | Throughout study |
| 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 | 13005 | France |
| Center Des Brules Hopital Cochin | Paris | F-75014 | 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 | 47023 | Italy |
| Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico | Palermo | 90127 | Italy |
| Wojskowy Instytut Medyczny | Warsaw | Poland |
| Emergency Clinic Hospital "Bagdazar-Arsenie" | Bucharest | Romania |
| Center for Burns & Reconstructive Surgery, University Hopsital Bratislava | Bratislava | 82107 | Slovakia |
| Clinic of Burns and Reconstructive Surgery Hospital Kosice | Kosice-Saca | 04015 | Slovakia |
| Queen Victoria Hospital | East Grinstead | RH19 3DZ | United Kingdom |
| The Burn Center Pinderfields Hospital | Wakefield | WF1 4EE | United Kingdom |
| 24074719 | Derived | Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26. |