None listed
Conditions
Interventions
Intervention1: Debrase Gel Dressing: Single / Double Local application
Control Intervention1: Nil: Nil
Sponsors
MediWound, Ltd. 42 Hayarkon Street North Industrial Area MediWound, Ltd.
Yavne, Israel 81227 Tel: 972-8-9324010 Fax: 972-8-9324011
InVentiv International Pharma Services B -101, Hamilton â?? B Hiranandani Business Park, Hiranandani Estate Ghodbunder Road Thane Maharashtra 400607
Max Neeman Medical International Ltd. Max House 1, Dr. Jha Marg Okhla Phase III New Delhi 110020
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females between 18 years and 55 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Burn composition must be as follows: a. Partial Thickness (mid & deep dermal) burn wounds ≥ 4% and ≤ 30% Total Body Surface Area (TBSA), b. Full thickness burns ≤ 5%, 4. All the partial and full thickness burn wounds must receive study treatment except facial, genital or perineal burns (Exclusion Criteria #5 and #6, below), 5. Total burn wounds ≤ 30% TBSA, 6. 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, 7. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. More than 5% TBSA full thickness burns, 2. Patient having only full thickness burns, 3. Other severe cutaneous trauma at the same sites as the burns (i.e. considerable blunt, avulsion or deep abrasion), or previous burn(s) at the same treatment site(s), 4. One or more burn wounds that do not meet study criteria, 5. Deep partial thickness and/or full thickness facial burn wounds >0.5% TBSA; study treatment of facial burns is not allowed, 6. Study treatment of perineal and/or genital burns is not allowed; A patient with these wounds may be enrolled but the wounds may not be designated as target wounds, 7. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling ≥ 80% of the trunk circumference), 8. A. The following pre enrolment dressings: a. Flamacerium, b. Silver Nitrate (AgNO3), B. Pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment); 9. Pre-enrolment escharotomy, 10. Heavily contaminated burns or pre-existing infections (WBC ≥ 20.0 X 103 cells/µ L), 11. Signs that may indicate smoke inhalation (e.g. clinical signs, etiology of injury, venue of injury, etc.), 12. Prisoners, 13. Pregnant women (positive pregnancy test) or nursing mothers, 14. Poorly controlled diabetes mellitus (HbA1c>9%), 15. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases), 16. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins), 17. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease), 18. Chronic systemic steroid intake, 19. History of allergy and/or known sensitivity to pineapples or papain, 20. Current suicide attempt, 21. Participation in another investigational drug trial, 22. Current alcohol or drug abuse,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is safety as measured by: 1. Systemic and local adverse events, 2. Changes in vital signs and laboratory tests, 3. Time to wound closure.Timepoint: Time to wound closure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Timely eschar removal (debridement), 2. % Treated wound excised (by tangential/minor/Versajet excision) or dermabraded in the first surgery. Surgical excision/dermabrasion performed in first surgery is defined as tangential/minor/Versajet excision or dermabrasion performed as the first surgical debridement performed after initial eschar removal (debridement) with DGD1, 3. % Treated wound autografted of deep dermal burns. The sum of all post- debridement autografts performed will be taken1. 4. Pharmacokinetic evaluation.Timepoint: % of treated wounds excised or dermabraded, PK Evaluation | — |
Countries
India
Contacts
Public ContactDr. Yashesh Mehta
Principal Investigator
Outcome results
None listed