Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 20, 2009

Primary Completion Date

December 2, 2015

Study Completion Date

December 2, 2015

Conditions
Burn
Interventions
DRUG

DGD

"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."

Trial Locations (2)

Unknown

Lok Nayak hospital, New Delhi

Soroka University Medical Center, Beersheba

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediWound Ltd

INDUSTRY