Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries
- Conditions
- Thermal Burn
- Registration Number
- NCT04040660
- Lead Sponsor
- MediWound Ltd
- Brief Summary
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.
- Detailed Description
This is an Expanded Access (treatment) protocol to allow ongoing treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study).
This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from DPT and FT thermal burns.
Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the specified entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will further allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns.
Prior to initiation of eschar removal treatment, patients will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions according to product instruction for use in order to ensure clean and moist eschar covered wound bed for NexoBrid application. Vital signs (Blood Pressure, Heart Rate and temperature) measurements and pain assessment will be performed within 24 hrs before start of treatment as well as haematology, biochemistry blood tests \& PTT/INR. Pressure measurements for circumferential extremity wounds will be performed 1 hour before start of treatment and will be closely monitored during treatment. Following wound cleansing and soaking treatments, patients will undergo the eschar removal process. TWs of up to 15% total body surface area (TBSA) will be treated with a single application of NexoBrid for 4 hours. Patients with TWs \>15% TBSA and up to 30% TBSA will be treated with 2 consecutive applications of 4 hours each. NexoBrid should not be applied to more than 15% TBSA in one session. PK samples will be taken from sub-set of patients with TWs area \>15% TBSA. Pressure measurements for circumferential extremity wounds will be performed after the removal of NexoBrid.
Post eschar removal completion, patients will undergo daily vital signs (Blood Pressure, Heart Rate and temperature measurements) and pain assessments for 1 week, starting on the morning following start of eschar removal. Blood tests (haematology and biochemistry) will be performed 24 ± 6 hrs post eschar removal as well as PTT/INR. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed.
Cosmesis (scar quality) evaluation (using MVSS) will be performed at 3 and 12 months post wound closure confirmation visit.
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Bayview Medical Center, Burn Center
🇺🇸Baltimore, Maryland, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, 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
Parkland Health & Hospital System, Burn Center
🇺🇸Dallas, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Valleywise Health Medical Center
🇺🇸Phoenix, Arizona, United States
University of California, Irvine
🇺🇸Orange, California, United States
Shands Children's Hospital, University of Florida
🇺🇸Gainesville, Florida, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Florida, Department of Surgery
🇺🇸Gainesville, Florida, 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
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Legacy Oregon Burn Center
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Colombia St Mary's Hospital
🇺🇸Milwaukee, Wisconsin, United States