Calendario›MDWD›DGD

DGD

Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care

Ensayo de MediWound Ltd. en Quemadura.

Fase

Fase 3

Estado

Completado

Participantes

182

previstos

Centros

17

Fin del objetivo primario

oct 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en dic 2005.

Qué mide

Co-primario: % de heridas tratadas escindidas (por excision tangencial/menor/Versajet) o dermoabrasion, en la primera cirugia, de heridas de espesor parcial profundo (Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroBurns 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).

Más ensayos de MDWD

Todos los de MDWD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00324311), actualizada en may 2011.