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

Completed · Not applicable

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT02380612

Run by

Avita Medical

People needed

30

Starts

2015-01-26

Expected to finish

2017-02-01

Last updated by the study team

2025-01-07

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
• The area of total burn injury is 5-50% TBSA inclusive.
• Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
• The subject is at least 5 years of age.
• The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
• The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
• The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
• The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

You may not qualify if…

• The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
• The subject is unable to follow the protocol.
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
• The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
• Life expectancy is less than 1 year.

Where it is running

• Arizona Burn Center at Maricopa Medical Center — Phoenix, Arizona, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• North Carolina Jaycee Burn Center — Chapel Hill, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• USAISR - US Army Institute of Surgical Research — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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