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DGD

Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns

Ensayo de MediWound Ltd. en Burn (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

36

previstos

Centros

2

Fin del objetivo primario

dic 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2009.

Qué mide

The primary endpoint is safety as measured by: 1. Systemic an local adverse events, 2. Changes in vital signs and laboratory tests, 3. Time to wound closure. (Throughout the study) (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 objectives of this study are as follows: 1. To evaluate the safety and efficacy (exploratory) of DGD in hospitalized patients with Partial Thickness (mid and deep dermal) thermal burns of 4-30% total body surface area (TBSA), but with total burn wounds of no more than 30% TBSA. Measures have already been taken in previous studies involving deeper wounds to control safety parameters (such as pain, fever and infection). Nevertheless, as part of the effort to expand the burn population in the future phase 3 study to the more superficial wound group, it is important to first explore these parameters in a small group involving this burn population. 2. To explore DGD absorption as measured by Pharmacokinetic testing.

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Ficha completa en ClinicalTrials.gov (NCT00898521), actualizada en sep 2021.