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
Concentration unit: g gram(s)
Concentration type: equal
Concentratio
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 = 5% and = 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment, 4. At least one wound of = 2% TBSA deep partial thickness and/or full thickness burn, 5. At least 50% of the deep partial thickness and/or full thickness burn wounds or burn wound area of the patient is intended for tangential excision as judged at hospital admission, 6. Total burn wounds = 30% TBSA, 7. 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, 8. Signed written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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, 4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling = 80% of the trunk circumference.) 5. Pre-enrollment dressings other than: none, dry clean, moist clean, saline, Silver Sulphadiazine (SSD), or 3%-5% Sulfamylon, 6. Pre-enrollment escharotomy, 7. Heavily contaminated burns or pre-existing infections (Adults: WBC = 20.0 cells/µL; Children aged 4-16: WBC = 25.0 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, atopic disease or known sensitivity to pineapples or papain, 18. Suicide attempts, 19. Participation in another investigational drug trial, 20. Current alcohol or drug abuse.
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): The primary end point is % treated wound excised (tangential and/or minor excision), in first surgery. First surgery is defined as tangential and/or minor excision performed (1) as the initial debridement procedure in the surgical SOC group, or (2) as the first surgical debridement performed after initial debridement, in the DGD or non-surgical debridement (NSD) SOC groups. The secondary end points are: • Time to complete wound closure • % Treated wound autografted Additional data as listed below will be collected to assess the direct clinical benefit to be derived from DGD treatment. • % Eschar removed from the treated wound by debridement procedure as per randomization group, • Time to start of debridement from time of injury, • Time to complete debridement, • Blood loss (as measured by volume of blood transfused), • Need for surgical escharotomy, • Interstitial/compartment pressure in circumferential extremity wounds (limb wounds which encircle = 80% of the limb circumference) prior to and following DGD or SOC treatments, • Time to hospital discharge, • General functional disability assessment, using a four point scale (none to severe), • Scarring assessments per wound, using a four point scale (none to severe). | — |
Countries
Czech Republic, Germany, Italy, Portugal, Slovakia, United Kingdom
Outcome results
None listed