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NCT02278718 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care

A Phase 3 study, sponsored by MediWound.

Completed
Registry status
Phase 3
Development phase
145
Enrollment target

NCT02278718: Completed Phase 3 study, sponsored by MediWound.

NCT02278718 is a Phase 3 study that has completed, run by MediWound. The registered enrollment target is 145 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02278718, a Phase 3 study, has completed, sponsored by MediWound.

COMPLETED
Registry status
Phase 3
Development phase
145 participants
Enrollment target

Study Summary

This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

Primary Outcome

Measured by a survival analysis of incidence of complete eschar removal as a function of time. Eschar removal will be measured at the end of the debridement starting from randomization date, assessed until complete eschar removal is achieved (in days)

Interventions

  • PROCEDURE Standard of Care
  • DRUG NexoBrid

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2015-05
Est. Completion 2022-12
Phase Phase 3
MediWound

7 total trials

What the finished NCT02278718 record still lists

NCT02278718 is an interventional study that assigns participants to a tested intervention. The registered 145 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 (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT02278718 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02278718 about?

NCT02278718 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care". This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal...

What is the current status of trial NCT02278718?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2015-05. Estimated completion is 2022-12.

What interventions are being tested in trial NCT02278718?

The interventions under investigation include: Standard of Care (PROCEDURE), NexoBrid (DRUG).

Who is sponsoring clinical trial NCT02278718?

This trial is sponsored by MediWound, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02278718's enrollment target sits among peer trials

145 1555th of 2000 higher than 442 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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Source: ClinicalTrials.gov NCT02278718, the US trial registry maintained by the National Library of Medicine. NCT02278718 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.