Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care - Full Text View

Sponsored by:	MediWound Ltd
Information provided by:	MediWound Ltd
ClinicalTrials.gov Identifier:	NCT00324311

Purpose

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).

Condition	Intervention	Phase
Burn	Drug: DGD	Phase III

MedlinePlus related topics: Burns Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

Further study details as provided by MediWound Ltd:

Primary Outcome Measures:

The primary end-point is % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery. [ Time Frame: Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (Debrase or non-surgical SOC groups). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary endpoints are time to complete wound closure and % treated wound autografted. [ Time Frame: Time to Wound Closure: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed; % Treated Wound Autografted: First post-debridement autografting procedure. ] [ Designated as safety issue: No ]

Estimated Enrollment:	172
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DGD: Experimental	Drug: DGD Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
SOC: Active Comparator	Drug: DGD Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

Detailed Description:

Ongoing study, recruiting adults and children.

Eligibility

Ages Eligible for Study:	4 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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,
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),

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324311

Contacts

Contact: Ronit Koren, PhD	972-8-9324003	ronitk@mediwound.co.il
Contact: Linda Gerstl, BSc	972-8-9324009	lindag@mediwound.co.il

Locations

Brazil
Pronto Socorro para Queimaduras de Goiania	Recruiting
Goiania, Brazil
Principal Investigator: Maria Tereza S Piccolo, MD
Hospital do Servidor Publico do Estado de Sao Paulo	Recruiting
Sao Paulo, Brazil
Principal Investigator: Debora CS Pinto, MD
Czech Republic
Burn Center University Hospital Brno-Bohunice	Withdrawn
Brno, Czech Republic, 62500
University Hospital of Kralovske Vinohrady Clinic of Burns Medicine	Withdrawn
Prague, Czech Republic, 10034/10
France
Centre de Traitment des Brules, Hopital Militaire Percy	Withdrawn
Paris, France, 92141
Center Des Brules Hopital Cochin	Recruiting
Paris, France, F-75014
Principal Investigator: Daniel Wassermann, MD
Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique	Recruiting
Marseille, France, 13005
Principal Investigator: Guy Magalon, MD
Germany
Klinikum Mannheim Universtatsklinikum	Recruiting
Mannheim, Germany
Principal Investigator: Ingo Koenigs, MD
Unfallkranken Berlin Burn Center	Recruiting
Berlin, Germany
Principal Investigator: Bernd Hartmann, MD
BG - Unfallklinik Ludwigshafen	Recruiting
Ludwigshafen, Germany
Principal Investigator: Gunter Germann, MD, Prof
Krankenhaus Oststadt Klinik fur Plastische, Hand & Wiederherstellungschirurgie	Recruiting
Hannover, Germany
Principal Investigator: Peter Vogt, MD, Prof
Klinikum Offenbach am Main	Recruiting
Offenbach, Germany
Principal Investigator: Henrik Menke, MD, Prof
Israel
Sheba Medical Center, Tel Hashomer	Recruiting
Ramat Gan, Israel
Principal Investigator: Josef Haik, MD
Soroka University Medical Center	Recruiting
Beer Sheba, Israel
Principal Investigator: Yuval Krieger, MD
Netherlands
Red Cross Hospital Burns Unit	Active, not recruiting
Beverwijk, Netherlands, 1940 EB
Poland
Klinika Chirurgii Urazowej	Active, not recruiting
Poznan, Poland
Wojskowy Instytut Medyczny	Recruiting
Warsaw, Poland
Principal Investigator: Wojciech Witkowski, MD
Portugal
Hospital of Saint Maria	Active, not recruiting
Lisbon, Portugal, 1600-003
Romania
Emergency Pediatric Hospital, "Grigore Alexandrescu"	Withdrawn
Bucharest, Romania
Emergency Clinic Hospital	Withdrawn
Bucharest, Romania
Emergency Clinic Hospital "Bagdazar-Arsenie"	Recruiting
Bucharest, Romania
Principal Investigator: Ioan Petre Florescu, Prof
County Clinical Hospital Plastic & Respiratory Surgery Dept	Recruiting
Timisoara, Romania
Principal Investigator: Tiberiu Bratu, Prof
Slovakia
Center for Burns & Reconstructive Surgery, University Hopsital Bratislava	Recruiting
Bratislava, Slovakia, 82107
Principal Investigator: Jan Koller, MD, CSc
Clinic of Burns and Reconstructive Surgery Hospital Kosice	Recruiting
Kosice-Saca, Slovakia, 04015
Principal Investigator: Jan Babik, MD, CSc
United Kingdom
University Hospital Birmingham	Active, not recruiting
Birmingham, United Kingdom, B29 6JD
Queen Victoria Hospital	Recruiting
East Grinstead, United Kingdom, RH19 3DZ
Principal Investigator: Philip Gilbert, MD, FRCS
The Burn Center Pinderfields Hospital	Active, not recruiting
Wakefield, United Kingdom, WF1 4EE

Sponsors and Collaborators

MediWound Ltd

Investigators

Study Chair:

Lior Rosenberg, MD

MediWound Ltd

More Information

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.

Responsible Party:	Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research & Development and Head of Global Clinical Operations ) )
Study ID Numbers:	MW2004-11-02
Study First Received:	May 10, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00324311
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 10, 2009