36
Participants
Start Date
December 20, 2009
Primary Completion Date
December 2, 2015
Study Completion Date
December 2, 2015
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."
Lok Nayak hospital, New Delhi
Soroka University Medical Center, Beersheba
Lead Sponsor
MediWound Ltd
INDUSTRY