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

NCT02278718 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-09-27

Study results available
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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).

Conditions

  • Thermal Burns

Interventions

DRUG

NexoBrid

NexoBrid is an enzymatic debriding agent for Eschar Removal.

PROCEDURE

Standard of Care

Surgical or Non-Surgical methods for Eschar Removal

Sponsors & Collaborators

  • MediWound Ltd

    lead INDUSTRY

Principal Investigators

  • Lior Rosenberg, Prof. · MediWound Ltd

  • Yaron Shoham, Dr. · MediWound Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2021-04-30
Completion
2022-12-31

Countries

  • United States
  • Belgium
  • Georgia
  • Germany
  • Hungary
  • India
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

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 NCT02278718 on ClinicalTrials.gov