Burn wounds defined as deep partial thickness or full thickness thermal burns.
Conditions
Interventions
Product Name: Debrase Gel Dressing
Product Code: Debrase Gel Dressing
Pharmaceutical Form: Gel
Current Sponsor code: Debrase Powder
Conc
Sponsors
MediWound Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 4 years to 55 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds > or = 5% and or = 2% TBSA deep partial thickness and/or full thickness burn, 5. At least 50% of the deep partial thickness and/or full thickness burn wound area of the patient is intended for surgical debridement as judged at hospital admission, 6. Total burn wounds =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s) or one or more burn wounds that do not meet study criteria, 2. Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA; study treatment of facial burns is not allowed, 3. Study treatment of perineal and/or genital burns (A patient with these wounds may be enrolled but the wounds may not be designated as target wounds.), 4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling > or = 80% of the trunk circumference.) 5. A. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3), B. Pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment), 6. Pre-enrollment escharotomy, 7. Heavily contaminated burns or pre-existing infections (Adults: WBC > or = 20.0 x 103 cells/µL; Children aged 4-16: WBC > or = 25.0 x 103 cells/µL), 8. Signs that may indicate smoke inhalation, 9. General condition of patient would contraindicate surgery, 10. Prisoners, 11. Pregnant women (positive pregnancy test) or nursing mothers, 12. Poorly controlled diabetes mellitus (HbA1c>9%), 13. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases), 14. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins), 15. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease), 16. Chronic systemic steroid intake, 17. History of allergy and/or known sensitivity to pineapples or papain, 18. Current suicide attempt 19. Participation in another investigational drug trial, 20. Current alcohol or drug abuse. 21. Analgesic intake which prevents the patient from understanding the objectives, nature and course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and full thickness thermal burns of 5-30% TBSA, but with total burn wounds of no more than 30% TBSA and to compare DGD to standard of care (SOC).;Secondary Objective: The purpose of this study is to identify the patient population that can best benefit from this new debriding agent and to provide evidence to confirm the clinical benefits of this agent. ; Primary end point(s): Two co-primary endpoints are: (1)The % treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery. Wounds which are entirely full thickness or have full thickness areas are excluded from this analysis. Surgical excision/dermabrasion performed in first surgery is defined as tangential/minor/Versajet excision or dermabrasion, performed (a) as the initial eschar removal (debridement) procedure in the surgical SOC group, or (b) as the first surgical debridement performed after initial eschar removal (debridement), in the DGD or non-surgical debridement (NSD) SOC groups. (2) The % treated wound autografted of deep partial wounds where the potential tissue-sparing effect may be seen. Wounds which are entirely full thickness or have full thickness areas are excluded from this analysis. (Footnote: Full thickness wounds require grafting due to lack of dermal remnants. The decision to graft combination wounds is often influenced by the presence of the full thickness component. Therefore, in order to show the clinical benefit of the tissue sparing effect of DGD, a homogenous wound population of deep partial thickness wounds will be included in this analysis.) The sum of all post-debridement autografts performed will be taken. | — |
Countries
Czech Republic, Germany, Italy, Portugal, Slovakia, United Kingdom
Outcome results
None listed