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

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

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
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 October 03, 2008

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