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

Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

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).

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Drug: DGD

Detailed Description

Completed study.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia
      • Royal Hospital Perth
• Brazil
  • Goiania, Brazil
    • Pronto Socorro para Queimaduras de Goiania
  • Sao Paulo, Brazil
    • Hospital do Servidor Publico do Estado de Sao Paulo
• France
  • Marseille, France, 13005
    • Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
  • Paris, France, F-75014
    • Center Des Brules Hopital Cochin
• Germany
  • Berlin, Germany
    • Unfallkrankenhaus Berlin Burn Center
  • Ludwigshafen, Germany
    • BG - Unfallklinik Ludwigshafen
  • Mannheim, Germany
    • Klinikum Mannheim Universtatsklinikum
• Israel
  • Beer Sheba, Israel
    • Soroka University Medical Center
• Italy
  • Cesena, Italy, 47023
    • Centro Grandi Ustionati
  • Palermo, Italy, 90127
    • Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico
• Poland
  • Warsaw, Poland
    • Wojskowy Instytut Medyczny
• Romania
  • Bucharest, Romania
    • Emergency Clinic Hospital "Bagdazar-Arsenie"
• Slovakia
  • Bratislava, Slovakia, 82107
    • Center for Burns & Reconstructive Surgery, University Hopsital Bratislava
  • Kosice-Saca, Slovakia, 04015
    • Clinic of Burns and Reconstructive Surgery Hospital Kosice
• United Kingdom
  • East Grinstead, United Kingdom, RH19 3DZ
    • Queen Victoria Hospital
  • Wakefield, United Kingdom, WF1 4EE
    • The Burn Center Pinderfields Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DGD	Drug: DGD; Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
ACTIVE_COMPARATOR: SOC	Drug: DGD; Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
% 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

Collaborators and Investigators

• Sponsor: MediWound Ltd

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: May 10, 2006
• First Submitted That Met QC Criteria: May 10, 2006
• First Posted (ESTIMATE): May 11, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): May 10, 2011
• Last Update Submitted That Met QC Criteria: May 8, 2011
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MW2004-11-02