A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Public ClinicalTrials.gov record NCT02148705. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02148705
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 77 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 27, 2015 (Actual)
- Primary completion
- Jun 12, 2018 (Actual)
- Completion
- Aug 20, 2020 (Actual)
- Last update posted
- Jul 10, 2024
2015 – 2020
United States locations
- U.S. sites
- 18
- U.S. states
- 17
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Department of Surgery | Mobile | Alabama | 36617 | — |
| Maricopa Medical Center | Phoenix | Arizona | 85008 | — |
| University of Colorado at Denver, Teaching | Aurora | Colorado | 80045 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida- Dept. of Surgery | Gainesville | Florida | 32610 | — |
| Joseph M. Still Research Foundation, Inc. | Augusta | Georgia | 30909 | — |
| The University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Burnett Burn Center at The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 8163 | — |
| The General Hospital Corporation d/b/a Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| New-York Presbyterian Hospital | New York | New York | 10065 | — |
| Emergency Medicine Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Lehigh Valley Hospital and Health Network | Allentown | Pennsylvania | 18103 | — |
| Regional Medical Center ,Regional One Health | Memphis | Tennessee | 38103 | — |
| University of Texas Medical Branch | Galveston | Texas | 77550 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| HarborView Medical Center | Seattle | Washington | 98104 | — |
| Columbia St. Mary's, Inc. | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02148705, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02148705 live on ClinicalTrials.gov.