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

NCT ID: NCT00324311

Last Updated: 2011-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-02-28

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DGD

Group Type: EXPERIMENTAL

DGD

Intervention Type: DRUG

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

SOC

Group Type: ACTIVE_COMPARATOR

DGD

Intervention Type: DRUG

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

Interventions

DGD

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

Intervention Type: DRUG

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),

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MediWound Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Neuroscience

Principal Investigators

Lior Rosenberg, MD

Role: STUDY_CHAIR

MediWound Ltd

Locations

Royal Hospital Perth

Perth, Western Australia, Australia

Pronto Socorro para Queimaduras de Goiania

Goiânia, , Brazil

Hospital do Servidor Publico do Estado de Sao Paulo

São Paulo, , Brazil

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

Marseille, , France

Center Des Brules Hopital Cochin

Paris, , France

Unfallkrankenhaus Berlin Burn Center

Berlin, , Germany

BG - Unfallklinik Ludwigshafen

Ludwigshafen, , Germany

Klinikum Mannheim Universtatsklinikum

Mannheim, , Germany

Soroka University Medical Center

Beersheba, , Israel

Centro Grandi Ustionati

Cesena, , Italy

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

Palermo, , Italy

Wojskowy Instytut Medyczny

Warsaw, , Poland

Emergency Clinic Hospital "Bagdazar-Arsenie"

Bucharest, , Romania

Center for Burns & Reconstructive Surgery, University Hopsital Bratislava

Bratislava, , Slovakia

Clinic of Burns and Reconstructive Surgery Hospital Kosice

Kosice-Saca, , Slovakia

Queen Victoria Hospital

East Grinstead, , United Kingdom

The Burn Center Pinderfields Hospital

Wakefield, , United Kingdom

Countries

Australia; Brazil; France; Germany; Israel; Italy; Poland; Romania; Slovakia; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 15555800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38837237 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24074719 (View on PubMed)

Other Identifiers

MW2004-11-02

Identifier Type: -

Identifier Source: org_study_id