Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns
Status:
Completed
Trial end date:
2015-12-02
Target enrollment:
Participant gender:
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.