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ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

NCT02380612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-07

Study results available
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Summary

This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.

Conditions

  • Burns

Interventions

DEVICE

ReCell Treatment

PROCEDURE

Skin Graft

Sponsors & Collaborators

  • MedDRA Assistance Inc

    collaborator UNKNOWN

  • Advanced Clinical Research Services, LLC

    collaborator OTHER

  • Avita Medical

    lead INDUSTRY

Principal Investigators

  • James H Holmes, IV, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-26
Primary Completion
2016-01-21
Completion
2017-02-01

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 NCT02380612 on ClinicalTrials.gov