A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Completed · Phase 3
Conditions studied: Thermal Burns
In brief
This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.
Key facts
- Study ID
- NCT02148705
- Run by
- MediWound Ltd
- People needed
- 175
- Starts
- 2015-05-27
- Expected to finish
- 2020-08-20
- Last updated by the study team
- 2024-07-10
Who can join
Age: 18 and older, up to 77. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of South Alabama Department of Surgery — Mobile, Alabama, United States
- Maricopa Medical Center — Phoenix, Arizona, United States
- University of Colorado at Denver, Teaching — Aurora, Colorado, United States
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
- University of Florida- Dept. of Surgery — Gainesville, Florida, United States
- Joseph M. Still Research Foundation, Inc. — Augusta, Georgia, United States
- The University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Burnett Burn Center at The University of Kansas Hospital — Kansas City, Kansas, United States
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
- The General Hospital Corporation d/b/a Massachusetts General Hospital — Boston, Massachusetts, United States
- New-York Presbyterian Hospital — New York, New York, United States
- Emergency Medicine Stony Brook University Hospital — Stony Brook, New York, United States
- Lehigh Valley Hospital and Health Network — Allentown, Pennsylvania, United States
- Regional Medical Center ,Regional One Health — Memphis, Tennessee, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- University of Utah Hospital — Salt Lake City, Utah, United States
- HarborView Medical Center — Seattle, Washington, United States
- Columbia St. Mary's, Inc. — Milwaukee, Wisconsin, United States
- University Hospital, Department of Plastic Surgery — Ghent, Belgium
- Klinika popálenin a rekonstrukční chirurgie, Fakultní nemocnice Brno — Brno, Czechia
- Khechinashvili University Hospital - Thermal Injuries — Tbilisi, Georgia
- Unfallkrankenhaus Berlin Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie — Berlin, Germany
- BG Universitätsklinikum Bergmannsheil GmbH — Bochum, Germany
- Rambam Medical Center — Haifa, Israel
- Hospital A. Cardarelli of Napoli — Naples, Italy
Full record on ClinicalTrials.gov
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