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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:
on-going recruitment, children and adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DGD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DGD | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Males and females between 2 years and 55 years of age,
Thermal burns caused by fire/flame, scalds or contact,
Burn composition must be as follows:
All the partial and full thickness burn wounds must receive study treatment except facial, genital or perineal burns (Exclusion Criteria #5 and #6 below),
Total burn wounds ≤ 30% TBSA,
Hospital admission within 24 hours of the burn injury. Patients transferred from another hospital/clinic may be enrolled if the primary admission was within 24 hours of the burn injury and admission to the burn unit participating in the study was within 48 hours of the burn injury,
Signed written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lior Rosenberg, MD | MediWound Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lok Nayak hospital | New Delhi | India | ||||
| Soroka University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15555800 | Background | Rosenberg L, Lapid O, Bogdanov-Berezovsky A, Glesinger R, Krieger Y, Silberstein E, Sagi A, Judkins K, Singer AJ. Safety and efficacy of a proteolytic enzyme for enzymatic burn debridement: a preliminary report. Burns. 2004 Dec;30(8):843-50. doi: 10.1016/j.burns.2004.04.010. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| Beersheba |
| Israel |