A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns (NCT02148705) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
United States175 participantsStarted 2015-05-27
Plain-language summary
This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects.
The study objectives are:
1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle,
2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC,
3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.
Who can participate
Age range18 Years – 77 Years
SexALL
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Inclusion criteria
✓. Males and females; ≥ 18
✓. Thermal burns caused by fire/flame, scalds or contact,
✓. Patient total burns area ≥ 3% DPT and / or FT,
✓. Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
✓. Informed consent can be obtained within 84 hours of the burn injury,
✓. Patients who are willing and able to sign a written consent form.
✓. At least one wound (a continuous burn area) that is ≥0.5% TBSA (DPT and/or FT) (this minimal wound size should not including face, perineal or genital area.
✓. SPT area that cannot be demarcated from DPT and FT areas should be less than 50% of the % TBSA of the TW.
Exclusion criteria
✕. Patients who are unable to follow study procedures and follow up period.
✕
What they're measuring
1
Primary Endpoint: Number of Participants With Complete Eschar Removal.
✕. 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) will be excluded from the study,
✕. Patients with electrical or chemical burns,
✕. Patients with circumferential (≥ 80% of the limb circumference) DPT and/or FT burns defined as Extremities at Risk (EAR) 2 as described in the protocol.
✕. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
✕. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of \> 12 hours SSD treatment),