EUCTR2005-003662-41-ITActive, not recruitingNot Applicable
Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- MEDIWOUND
- Enrollment
- 270
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 wound area of the patient is intended for surgical debridement 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: 0
- •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
- •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 anrolled but the wounds may not be deisgnated as target wounds), 4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling ≥ 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 ≥ 20.0 x 103 cells/µL; Children aged 4-16: WBC ≥ 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 attempts, 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.
Investigators
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