Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries (NCT04040660) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries
United States
Plain-language 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.
Who can participate
Age range
0 Years
Sex
ALL
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Inclusion criteria
. 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 .
Exclusion criteria
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.
. 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,