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NCT02148705 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
A Phase 3 study, sponsored by MediWound.
- Completed
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT02148705: Completed Phase 3 study, sponsored by MediWound.
NCT02148705 is a Phase 3 study that has completed, run by MediWound. The registered enrollment target is 175 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02148705, a Phase 3 study, has completed, sponsored by MediWound.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study 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.
Primary Outcome
Comparison of NexoBrid over Gel Vehicle for eschar removal as measured by Number of Participants with complete eschar removal at the end of the topical agent soaking period by a blinded assessor.
Interventions
- PROCEDURE Standard of Care (SOC)
- DRUG Gel Vehicle
- DRUG NexoBrid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2015-05-27 |
| Est. Completion | 2020-08-20 |
| Phase | Phase 3 |
What the finished NCT02148705 record still lists
NCT02148705 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care (SOC) is the first listed.
NCT02148705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02148705 about?
NCT02148705 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns". 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 com...
What is the current status of trial NCT02148705?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2015-05-27. Estimated completion is 2020-08-20.
What interventions are being tested in trial NCT02148705?
The interventions under investigation include: Standard of Care (SOC) (PROCEDURE), Gel Vehicle (DRUG), NexoBrid (DRUG).
Who is sponsoring clinical trial NCT02148705?
This trial is sponsored by MediWound, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02148705's enrollment target sits among peer trials
175 1440th of 2000 higher than 559 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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