CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

Completed · Not applicable

Conditions studied: Burns

In brief

The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.

Key facts

Study ID

NCT02994654

Run by

Avita Medical

People needed

12

Starts

2016-10-01

Expected to finish

2018-09-01

Last updated by the study team

2024-07-30

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 follow-up 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 1year.

Where it is running

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

Full record on ClinicalTrials.gov

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