Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
1 other identifier
observational
100
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
December 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 3, 2020
July 1, 2020
5 years
December 12, 2016
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Wound Healing
\> 95% epithelialization with a contiguous layer of viable epithelium
Wound healing assessed at all study visits
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avita Medicallead
Study Sites (22)
University of South Alabama Department of Surgery
Mobile, Alabama, 36688, United States
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, 85008, United States
University of California San Diego Regional Burn Center
San Diego, California, 92103-8896, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Joseph M Still Research Foundation
Augusta, Georgia, 30909, United States
Richard M. Fairbanks Burn Center at Eskenazi Health
Indianapolis, Indiana, 46202, United States
Baton Rouge General Regional Burn Center
Baton Rouge, Louisiana, 70809, United States
University Medical Center
New Orleans, Louisiana, 70112, United States
Maine Medical Center
Portland, Maine, 04102, United States
Walter Reed National Military Medical Center Bethesda
Bethesda, Maryland, 20889, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Shriner's Boston
Boston, Massachusetts, 02114, United States
MS Burn & Reconstruction Center, Merit Health Central
Jackson, Mississippi, 39204, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
Mercy General Burn Center - Springfield
Springfield, Missouri, 65804, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38103-3409, United States
U.S.Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234-7767, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2016
First Posted
December 14, 2016
Study Start
May 1, 2014
Primary Completion
May 1, 2019
Study Completion
June 1, 2020
Last Updated
August 3, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share