Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    MediWound Ltd
Updated on 7 November 2020
debridement
thermal burn
third degree burn
systemic infection
scald

Summary

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 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.

Description

on-going recruitment, children and adults

Details
Condition Burns
Treatment DGD
Clinical Study IdentifierNCT00898521
SponsorMediWound Ltd
Last Modified on7 November 2020

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