Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care

NCT00324311 | Completed Phase 3 DMC

• 1 other identifier: MW2004-11-02
• Study Type: interventional
• Target: 182
• Locations: 10 countries
• Sites: 17

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).

Conditions

Burn

Outcome Measures

Primary Outcomes (2)

• Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds

  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

  Post-debridement autografts

Secondary Outcomes (4)

• % 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

Study Arms (2)

DGD

EXPERIMENTAL

Drug: DGD

SOC

ACTIVE COMPARATOR

Drug: DGD

Interventions

DGD DRUG

Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

DGD; SOC

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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),

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (17)

Royal Hospital Perth

Perth, Western Australia, Australia

Location

Pronto Socorro para Queimaduras de Goiania

Goiânia, Brazil

Location

Hospital do Servidor Publico do Estado de Sao Paulo

São Paulo, Brazil

Location

Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique

Marseille, 13005, France

Location

Center Des Brules Hopital Cochin

Paris, F-75014, France

Location

Unfallkrankenhaus Berlin Burn Center

Berlin, Germany

Location

BG - Unfallklinik Ludwigshafen

Ludwigshafen, Germany

Location

Klinikum Mannheim Universtatsklinikum

Mannheim, Germany

Location

Soroka University Medical Center

Beersheba, Israel

Location

Centro Grandi Ustionati

Cesena, 47023, Italy

Location

Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico

Palermo, 90127, Italy

Location

Wojskowy Instytut Medyczny

Warsaw, Poland

Location

Emergency Clinic Hospital "Bagdazar-Arsenie"

Bucharest, Romania

Location

Center for Burns & Reconstructive Surgery, University Hopsital Bratislava

Bratislava, 82107, Slovakia

Location

Clinic of Burns and Reconstructive Surgery Hospital Kosice

Kosice-Saca, 04015, Slovakia

Location

Queen Victoria Hospital

East Grinstead, RH19 3DZ, United Kingdom

Location

The Burn Center Pinderfields Hospital

Wakefield, WF1 4EE, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 15555800 BACKGROUND

• Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.

  PMID: 38837237 DERIVED

• 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.

  PMID: 24074719 DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lior Rosenberg, MD

  MediWound Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 11, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2010
• Last Updated: May 10, 2011

Record last verified: 2009-07

Locations

RO (1); FR (2); DE (3); PL (1); GB (2); AU (1); BR (2); IL (1); IT (2); SL (2)