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Sponsored by: |
MediWound Ltd |
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Information provided by: | MediWound Ltd |
ClinicalTrials.gov Identifier: | NCT00324311 |
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 |
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) |
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 |
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DGD: Experimental |
Drug: DGD
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
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SOC: Active Comparator |
Drug: DGD
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
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Ongoing study, recruiting adults and children.
Ages Eligible for Study: | 4 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ronit Koren, PhD | 972-8-9324003 | ronitk@mediwound.co.il |
Contact: Linda Gerstl, BSc | 972-8-9324009 | lindag@mediwound.co.il |
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 |
Study Chair: | Lior Rosenberg, MD | MediWound Ltd |
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 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health |
Burns Wounds and Injuries Disorders of Environmental Origin |
Burns Wounds and Injuries Disorders of Environmental Origin |