Status:
COMPLETED
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
Lead Sponsor:
Avita Medical
Collaborating Sponsors:
Advanced Clinical Research Services, LLC
Conditions:
Burns
Eligibility:
All Genders
5+ years
Brief Summary
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 Harvestin...
Detailed Description
Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Rege...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2019
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03333941
Start Date
October 26 2017
End Date
May 8 2019
Last Update
July 30 2024
Active Locations (6)
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1
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, United States, 85008
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
University Medical Center
New Orleans, Louisiana, United States, 70112