Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries
Public ClinicalTrials.gov record NCT04040660. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by previous clinical studies. The depth determination is important for the planning and execution of the post eschar removal stage of wound closure phase (grafting or spontaneous epithelialization). Additional clinically meaningful attributes of NexoBrid enzymatic eschar removal is the ability to lower surgical burden as it allows to remove eschar in wounds that otherwise would have to undergo surgical excision as no other non-surgical treatment is available for early and effective eschar removal. MediWound has completed the recruitment of patients to study MW2010-03-02 (DETECT Study). The timeline for patients' follow-up and potential for approval in 2021/2022, creates a significant gap in the ability of clinical practitioner's to maintain their knowledge and skills in using NexoBrid as they no longer treat eligible patients. The expanded access protocol will allow to expand treatment to additional patients in up to 30 US burn centers (DETECT sites and additional sites). The proposed protocol will allow product availability to eligible population and keep the clinical use of the product knowledge active in the burn care community introducing it to their routine burn care. The BLA assessment was completed and NexoBrid is approved for use in adults in the US. Adult enrollment is closed, and only pediatric patients will continue to be recruited for this treatment protocol. The purpose of this treatment protocol is to provide NexoBrid to patients with DPT and FT thermal burns on up to 30% TBSA. This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in this patient population.
Study identification
- NCT ID
- NCT04040660
- Recruitment status
- Approved For Marketing
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Aug 29, 2024
United States locations
- U.S. sites
- 28
- U.S. states
- 23
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36617 | — |
| Valleywise Health Medical Center | Phoenix | Arizona | 85008 | — |
| University of California, Irvine | Orange | California | 92868 | — |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands Children's Hospital, University of Florida | Gainesville | Florida | 32610 | — |
| University of Florida, Department of Surgery | Gainesville | Florida | 32610 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Bayview Medical Center, Burn Center | Baltimore | Maryland | 21224 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Hennepin Healthcare | Minneapolis | Minnesota | 55415 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Legacy Oregon Burn Center | Portland | Oregon | 97227 | — |
| Lehigh Valley Hospital and Health Network | Allentown | Pennsylvania | 18103 | — |
| UPMC Mercy Burn Center | Pittsburgh | Pennsylvania | 15219 | — |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Parkland Health & Hospital System, Burn Center | Dallas | Texas | 75235 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| Colombia St Mary's Hospital | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04040660, 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 Aug 29, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04040660 live on ClinicalTrials.gov.