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

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324311
• Other study ID #: MW2004-11-02
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2006
• Last updated: May 8, 2011
• Start date: December 2005
• Est. completion date: February 2010

Study information

• Verified date: July 2009
• Source: MediWound Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Description:

Completed study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: February 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Drug:
• DGD
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MediWound Ltd

Countries where clinical trial is conducted

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Co-primary: % treated wound autografted of deep partial wounds		Post-debridement autografts	No
Secondary	% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds		As for primary endpoint	No
Secondary	Time to complete wound closure		% epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed	No
Secondary	Timely eschar removal		Debridement procedures	No
Secondary	Blood loss		Throughout study	Yes