A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared t… (NCT02278718) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
United States145 participantsStarted 2015-05
Plain-language summary
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).
Who can participate
Age range0 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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,
Exclusion criteria
✕. 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,
What they're measuring
1
Time to Complete Eschar Removal (in Days)
Timeframe: From randomization date until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm.
✕. 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),