Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries

APPROVED_FOR_MARKETING

Conditions studied: Thermal Burn

In brief

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.

Key facts

Study ID

NCT04040660

Run by

MediWound Ltd

Last updated by the study team

2024-08-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Valleywise Health Medical Center — Phoenix, Arizona, United States
• University of California, Irvine — Orange, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands Children's Hospital, University of Florida — Gainesville, Florida, United States
• University of Florida, Department of Surgery — Gainesville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Eskenazi Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• The University of Kansas Hospital — Kansas City, Kansas, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins Bayview Medical Center, Burn Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hennepin Healthcare — Minneapolis, Minnesota, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Legacy Oregon Burn Center — Portland, Oregon, United States
• Lehigh Valley Hospital and Health Network — Allentown, Pennsylvania, United States
• UPMC Mercy Burn Center — Pittsburgh, Pennsylvania, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Parkland Health & Hospital System, Burn Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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