Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
- Conditions
- Burns
- Registration Number
- NCT02992249
- Lead Sponsor
- Avita Medical
- Brief Summary
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- The patient requires treatment of a life-threatening wound requiring grafting.
- Patient has inadequate available skin to harvest for conventional skin grafting.
- The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition.
- In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device.
- Patient is hemodynamically stable.
- The patient (or legal representative) is able to read and understand instructions and give informed consent.
- The patient has active infection at the proposed ReCell treatment site.
- The patient is unable to follow the protocol.
- The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound Healing Wound healing assessed at all study visits \> 95% epithelialization with a contiguous layer of viable epithelium
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Joseph M Still Research Foundation
🇺🇸Augusta, Georgia, United States
Arizona Burn Center at Maricopa Integrated Health Systems
🇺🇸Phoenix, Arizona, United States
University of South Alabama Department of Surgery
🇺🇸Mobile, Alabama, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of California San Diego Regional Burn Center
🇺🇸San Diego, California, United States
Baton Rouge General Regional Burn Center
🇺🇸Baton Rouge, Louisiana, United States
University Medical Center
🇺🇸New Orleans, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
MS Burn & Reconstruction Center, Merit Health Central
🇺🇸Jackson, Mississippi, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Children's Mercy Kansas City
🇺🇸Kansas City, Missouri, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, 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
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Shriner's Boston
🇺🇸Boston, Massachusetts, United States
Richard M. Fairbanks Burn Center at Eskenazi Health
🇺🇸Indianapolis, Indiana, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Walter Reed National Military Medical Center Bethesda
🇺🇸Bethesda, Maryland, United States
Mercy General Burn Center - Springfield
🇺🇸Springfield, Missouri, United States