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 States, Belgium, Czechia175 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 range
18 Years – 77 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Endpoint: Number of Participants With Complete Eschar Removal.
. 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.
. Modified Baux index ≥ 80,
. 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),