Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- MediWound Ltd
- Enrollment
- 182
- Locations
- 17
- Primary Endpoint
- Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Study Overview
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 local and/or systemic infection or sepsis. The local inflammation and infection destroy healthy surrounding tissues and extends the original damage. In order to prevent these complications, and in order to minimize the risk of infection, it is imperative to evaluate the burn and remove all of the offending eschar at the earliest possible opportunity. This removal of dead tissue is termed "debridement".
The most direct debridement method for eschar removal is surgery. Traditional, conservative non-surgical debridement is a lengthy process which often involves many complications.
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/or full thickness thermal burns and to compare DGD to standard of care (SOC).
Detailed Description
Completed study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 55 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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),
Arms & Interventions
DGD
Intervention: DGD (Drug)
SOC
Intervention: DGD (Drug)
Outcomes
Primary Outcomes
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Time Frame: Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Co-primary: % treated wound autografted of deep partial wounds
Time Frame: Post-debridement autografts
Secondary Outcomes
- % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds(As for primary endpoint)
- Time to complete wound closure(% epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed)
- Timely eschar removal(Debridement procedures)
- Blood loss(Throughout study)