Clinical trial NCT00324311: Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Official title: Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burn
Lead sponsor: MediWound Ltd
Sponsor class: INDUSTRY
First posted: 2006-05-11
Enrollment: 182
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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. Total burn wounds ≤ 30% TBSA,
6. Signed written informed consent.

Exclusion Criteria:

1. Deep partial thickness and/or full thickness facial burn wounds, \> 0.5% TBSA; study treatment of facial burns is not allowed,
2. 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),
3. Circumferential anterior/posterior trunk full thickness fire/flame burns, \> 15% TBSA, (Circumferential is defined as encircling ≥ 80% of the trunk circumference.)
4. Pre-enrollment escharotomy,
5. Heavily contaminated burns or pre-existing infections,
6. Signs that may indicate smoke inhalation,
7. General condition of patient would contraindicate surgery,
8. Pregnant women (positive pregnancy test) or nursing mothers,
9. Poorly controlled diabetes mellitus (HbA1c\>9%),
10. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
11. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
12. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),

Primary outcomes:
measure: Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
timeFrame: Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
measure: Co-primary: % treated wound autografted of deep partial wounds
timeFrame: Post-debridement autografts
Secondary outcomes:
measure: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
timeFrame: As for primary endpoint
measure: Time to complete wound closure
timeFrame: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
measure: Timely eschar removal
timeFrame: Debridement procedures
measure: Blood loss
timeFrame: Throughout study
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Hospital Perth
state: Western Australia
city: Goiania
country: Brazil
facility: Pronto Socorro para Queimaduras de Goiania
city: Sao Paulo
country: Brazil
facility: Hospital do Servidor Publico do Estado de Sao Paulo
city: Marseille
country: France
facility: Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
city: Paris
country: France
facility: Center Des Brules Hopital Cochin
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin Burn Center
city: Ludwigshafen
country: Germany
facility: BG - Unfallklinik Ludwigshafen
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universtatsklinikum
city: Beer Sheba
country: Israel
facility: Soroka University Medical Center
city: Cesena
country: Italy
facility: Centro Grandi Ustionati
city: Palermo
country: Italy
facility: Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Bucharest
country: Romania
facility: Emergency Clinic Hospital "Bagdazar-Arsenie"
city: Bratislava
country: Slovakia
facility: Center for Burns & Reconstructive Surgery, University Hopsital Bratislava
city: Kosice-Saca
country: Slovakia
facility: Clinic of Burns and Reconstructive Surgery Hospital Kosice
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
city: Wakefield
country: United Kingdom
facility: The Burn Center Pinderfields Hospital
Study officials:
affiliation: MediWound Ltd
name: Lior Rosenberg, MD
role: STUDY_CHAIR
References:
citation: Rosenberg L, Lapid O, Bogdanov-Berezovsky A, Glesinger R, Krieger Y, Silberstein E, Sagi A, Judkins K, Singer AJ. Safety and efficacy of a proteolytic enzyme for enzymatic burn debridement: a preliminary report. Burns. 2004 Dec;30(8):843-50. doi: 10.1016/j.burns.2004.04.010.
citation: Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.