Status:
COMPLETED
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Lead Sponsor:
MediWound Ltd
Conditions:
Burn
Eligibility:
All Genders
4-55 years
Phase:
PHASE3
Brief Summary
Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is the source of l...
Detailed Description
Completed study.
Eligibility Criteria
Inclusion
- Males and females between 4 years to 55 years of age,
- Thermal burns caused by fire/flame, scalds or contact,
- 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,
- At least one wound of ≥ 2% TBSA deep partial thickness and/or full thickness burn,
- Total burn wounds ≤ 30% TBSA,
- Signed written informed consent.
Exclusion
- Deep partial thickness and/or full thickness facial burn wounds, \> 0.5% TBSA; study treatment of facial burns is not allowed,
- 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),
- Circumferential anterior/posterior trunk full thickness fire/flame burns, \> 15% TBSA, (Circumferential is defined as encircling ≥ 80% of the trunk circumference.)
- Pre-enrollment escharotomy,
- Heavily contaminated burns or pre-existing infections,
- Signs that may indicate smoke inhalation,
- General condition of patient would contraindicate surgery,
- Pregnant women (positive pregnancy test) or nursing mothers,
- Poorly controlled diabetes mellitus (HbA1c\>9%),
- Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
- Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
- Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00324311
Start Date
December 1 2005
End Date
February 1 2010
Last Update
May 10 2011
Active Locations (17)
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1
Royal Hospital Perth
Perth, Western Australia, Australia
2
Pronto Socorro para Queimaduras de Goiania
Goiânia, Brazil
3
Hospital do Servidor Publico do Estado de Sao Paulo
São Paulo, Brazil
4
Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
Marseille, France, 13005