Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns
Recruitment status was Recruiting
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:
- 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.
- To explore DGD absorption as measured by Pharmacokinetic testing.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns (Children & Adults)- Protocol MW2008-09-03|
- 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. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
DGD is a mixture of lyophilized enzymes derived from purified Bromelain from pineapple stem.
Two grams or 5 grams of Debrase powder are dissolved in 20 grams or 50 grams of Gel Vehicle to obtain DGD. DGD is applied to the burn wound at a dose of 2g Debrase/20g Gel per 100 cm2 of skin or 5g Debrase/50g Gel per 250 cm2 for a duration of four hours. In an average human adult, 100 cm2 represents approximately 1% of Total Body Surface Area (TBSA).
Please note that for individuals of exceptional size (e.g. children), it is important to calculate the dosage based on the 100 cm2 measurement.
The Debrase powder and the Gel Vehicle are to be mixed at the patient bedside for a maximum of 15 min prior to use.
DGD should not be applied to more than 15% TBSA in one session. If the wound area to be treated is more than 15% TBSA, DGD should be applied in two or more separate sessions.
DGD should not be applied more than twice to the same burn wound area.
on-going recruitment, children and adults
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898521
|Contact: Keren David, M.Scfirstname.lastname@example.org|
|Lok Nayak hospital||Active, not recruiting|
|Soroka University Medical Center||Recruiting|
|Beer Sheva, Israel|
|Principal Investigator: Yuval Krieger, MD|
|Study Chair:||Lior Rosenberg, MD||MediWound Ltd|