CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
ReCell and Split-thickness skin graftdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01138917
NCT01138917N/ACompleted
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A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

Avita Medical·interventional·Posted Jun 8, 2010·Updated May 13, 2019

In Brief

A clinical study evaluating ReCell and Split-thickness skin graft for Burns. Completed, enrolled 101 participants across 12 sites.

Detailed Summary

This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesUnited States
CollaboratorsUnited States Department of Defense, Royal Perth Hospital, MedDRA Assistance Inc, BioStat International, Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2010
Enrollment StartMay 21, 2010
Primary CompletionAug 29, 2014
Study CompletionAug 26, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.1 years ago

Interventions

ReCell and Split-thickness skin graftdevice

The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.