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Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries

NCT04040660 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

  • Thermal Burn

Interventions

DRUG

NexoBrid

NexoBrid is presented as lyophilized powder and gel vehicle for preparation of a gel for cutaneous use. The API is a concentrate of proteolytic enzymes enriched in Bromelain extracted from the stem of Ananas comosus (pineapple plant)

Sponsors & Collaborators

  • MediWound Ltd

    lead INDUSTRY

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04040660 on ClinicalTrials.gov