Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

Completed

Conditions studied: Burns

In brief

The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.

Key facts

Study ID

NCT03333941

Run by

Avita Medical

People needed

76

Starts

2017-10-26

Expected to finish

2019-05-08

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.
• Area(s) requiring skin grafting at least 320 square centimeters.
• 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.
• Pregnant or lactating women.

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
• University Medical Center — New Orleans, Louisiana, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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