Completed

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

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What is being tested

ReCell and Split-thickness skin graft

Device
Who is being recruted

Burns

+ Wounds and Injuries

From 18 to 65 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorAvita Medical
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 21, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleA Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
NCT01138917
Principal SponsorAvita Medical
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

101 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BurnsWounds and Injuries

Criteria

11 inclusion criteria required to participate
The subject requires primary skin grafting as a result of an acute thermal burn injury
The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
The area of total burn injury is 1-20% TBSA
The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
Show More Criteria
9 exclusion criteria prevent from participating
The subject is unable to follow the protocol
The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
The total subject burn injury is less than 1% or more than 20% TBSA
The subject has a microbiologically proven pre-existing local or systemic bacterial infection
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All participants will receive both ReCell and split-thickness skin graft

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

Arizona Burn Center at Maricopa Integrated Health Systems

Phoenix, United StatesOpen Arizona Burn Center at Maricopa Integrated Health Systems in Google Maps
Suspended

University of California Davis Regional Burn Center

Sacramento, United States
Suspended

The Burn Center at Washington Hospital Center

Washington D.C., United States
Suspended

Shands Burn Center at University of Florida

Gainesville, United States
Completed12 Study Centers