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

NCT04040660 | Unknown

• 1 other identifier: MW2018-06-21
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 28

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.

Conditions

Thermal Burn

Interventions

NexoBrid DRUG

NexoBrid is presented as lyophilized powder and gel vehicle for preparation of a gel for cutaneous use. The API is a concentrate of proteolytic enzymes enriched in Bromelain extracted from the stem of Ananas comosus (pineapple plant)

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric only (0 to \< 18years old) males and females
• Thermal burns caused by fire/flame, scalds or contact,
• Patient total burns area ≥ 1% DPT and / or FT with eschar that should be removed in SOC,
• Patient total burns area to be treated should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
• Informed consent can be obtained within 84h of the burn injury,
• Patients and/or legal authorized representative who are willing and able to sign a written consent .
• At least one wound (a continuous burn area) that is ≥0.5% TBSA (DPT and/or FT) (this minimal wound size should not include face, perineal or genital)
• All planned TWs should meet the following criteria:
• SPT areas that cannot be demarcated from DPT and FT areas should be less than 50% of the % TBSA of the TW,
• Wound's blisters can be removed/ unroofed, as judged by the investigator.

You may not qualify if:

• Patients weighing less than 3kg,
• Patients with burned, charred fingers, 3rd degree in depth and possibly devoid of circulation,
• Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid),
• Patients with pre enrolment escharotomy,
• Patients with electrical or chemical burns,
• The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
• Patients with pre-enrolment wounds which are covered by eschar heavily saturated with Silver, Iodine or by SSD pseudoeschar (pseudoeschar as a result of \> 12 hrs SSD treatment),
• Patients with diagnosed infections as described in the protocol,
• Diagnosis of smoke inhalation injury \[12\],
• Pregnant women (serum positive pregnancy test) or nursing mothers,
• Poorly controlled diabetes mellitus (HbA1c\>11%) in patients with known diabetes as captured in the medical history,
• BMI greater than 40.0 kg/m2,
• American Society of Anesthesiologists (ASA) physical status classification system greater than 2
• Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable Ischemic Heart Disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma or uncontrolled asthma),
• Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins),

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (28)

University of South Alabama

Mobile, Alabama, 36617, United States

Location

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Shands Children's Hospital, University of Florida

Gainesville, Florida, 32610, United States

Location

University of Florida, Department of Surgery

Gainesville, Florida, 32610, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Bayview Medical Center, Burn Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Legacy Oregon Burn Center

Portland, Oregon, 97227, United States

Location

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, 18103, United States

Location

UPMC Mercy Burn Center

Pittsburgh, Pennsylvania, 15219, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Parkland Health & Hospital System, Burn Center

Dallas, Texas, 75235, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Colombia St Mary's Hospital

Milwaukee, Wisconsin, 53211, United States

Location

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 1, 2019
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

US (28)