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
Status: | Completed |
---|---|
Conditions: | Other Indications, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 5 - Any |
Updated: | 12/26/2018 |
Start Date: | October 2016 |
End Date: | September 2018 |
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.
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.
Inclusion Criteria:
1. 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).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous),
excluding hand/face and joints.
4. The subject is at least 5 years of age.
5. 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.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of
the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical
trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give
informed, voluntary, written consent.
Exclusion Criteria:
1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive
substances.
2. The subject is unable to follow the protocol.
3. The subject has other concurrent conditions that in the opinion of the investigator
may compromise patient safety or study objectives.
4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for
irrigation (Hartmann's) solution.
5. Life expectancy is less than 1year.
We found this trial at
6
sites
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1 Tampa General Cir
Tampa, Florida 33606
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: David J. Smith, M.D.
Phone: 813-844-4133
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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3698 Chambers Road
Fort Sam Houston, Texas 78234
Fort Sam Houston, Texas 78234
Principal Investigator: Booker King, MD
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Memphis, Tennessee 38163
Principal Investigator: William L. Hickerson, MD, FACS
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Phoenix, Arizona 85008
Principal Investigator: Kevin Foster, MD, MBA,FACS
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Winston-Salem, North Carolina 27157
Principal Investigator: James H. Holmes IV, MD
Phone: 336-716-4278
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