A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care

Completed · Phase 3

Conditions studied: Thermal Burns

In brief

This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

Key facts

Study ID: NCT02278718
Run by: MediWound Ltd
People needed: 145
Starts: 2015-05-01
Expected to finish: 2022-12-01
Last updated by the study team: 2024-09-27

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Stage 1: Males and females between 4 years to 18 years of age, Stage 2 (upon DSMB review): Males and females between 1 year to 18 years of age, Stage 3 (upon DSMB review): Males and females between 0 years to 18 years of age.
Thermal burns caused by fire/flame, scalds or contact.
Patient total burns area ≥ 1% DPT and / or FT,
Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
Signed written informed consent by a legal guardian can be obtained within 84 hours of the burn injury.
At least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:
Wound that is ≥ 1% TBSA (DPT and/or FT) (not including face, perineal or genital),
Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,
Wound that is potentially intended for surgical eschar removal,
Wound's blisters can be unroofed, as judged by the investigator.

You may not qualify if…

Patients weighing less than 3kg,
Patients who are unable to follow study procedures and follow up period,
Patients with electrical or chemical burns,
Patient with a continuous burn area above 15% TBSA,
Patients with no DPT and/or FT burn area (only SPT wounds),
Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling ≥ 80% of the trunk circumference),
The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
Patients with diagnosed infections,
Diagnosis of smoke inhalation injury,
Patients with pre-enrolment wounds which are covered by eschar saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of >12h SSD treatment),
Patients with pre-enrolment escharotomy,
Pregnant women (positive pregnancy test) or nursing mothers,
Poorly controlled diabetes mellitus (HbA1c>9%),
Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, uncontrolled asthma,
Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
Any known conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),
ASA greater than 2
Chronic systemic steroid intake,
History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
Current (within 12 months prior to screening) suicide attempt,
Enrollment in any investigational drug trial within 4 weeks prior to screening,
Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse,
Prisoners and incarcerated
Patients who might depend on the clinical study site or investigator.
Patient expresses objection to participate in the study.

Where it is running

Maricopa Special Health Care District — Phoenix, Arizona, United States
University Of Florida — Gainesville, Florida, United States
University of Miami — Miami, Florida, United States
The University of South Florida Board of Trustees — Tampa, Florida, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
Shriners Hospital for Children — Boston, Massachusetts, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
Legacy Emanuel Hospital & Health Center dba Legacy Research Institute — Portland, Oregon, United States
Drexel University — Philadelphia, Pennsylvania, United States
Shawn Jekins Children's Hospital — Charleston, South Carolina, United States
University of Utah — Salt Lake City, Utah, United States
Harborview Medical Center — Seattle, Washington, United States
University Hospital, Department of Plastic Surgery — Ghent, Belgium
S. Khechinashvili University Hospital — Tbilisi, Georgia
Unfallkrankenhaus Berlin Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie — Berlin, Germany
Klinikum Stuttgart - Olgahospital — Stuttgart, Germany
MRE Bethesda Gyermekkórháza — Budapest, Hungary
B.A.Z Megyei Kórház és Egyetemi Oktatókórház — Miskolc, Hungary
Klinikai Kozpont Gyermekgyogyaszati Klinika — Pécs, Hungary
Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg — New Delhi, National Capital Territory of Delhi, India
Krishna Rajendra Hospital — Mysuru, India
Vardhman Mahavir Medical College (VLCC) and Safdarjung Hospital — New Delhi, India
Universitary Integrated Hospital Verona (AOUI Verona), — Verona, Italy
Acute Burn Care &Trauma Surgery, Dept Surgery/Burn Center, Rode Kruis Ziekenhuis, LUMC University Leiden — Beverwijk, Netherlands

Full record on ClinicalTrials.gov

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