Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

Burns Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992249
• Other study ID #: CTP004
• Status: Completed
• Start date: May 2014
• Est. completion date: June 2020

Study information

• Verified date: July 2020
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Burns

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Joseph M Still Research Foundation	Augusta	Georgia
United States	Baton Rouge General Regional Burn Center	Baton Rouge	Louisiana
United States	Walter Reed National Military Medical Center Bethesda	Bethesda	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Shriner's Boston	Boston	Massachusetts
United States	University of Missouri Health Care	Columbia	Missouri
United States	U.S.Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Richard M. Fairbanks Burn Center at Eskenazi Health	Indianapolis	Indiana
United States	MS Burn & Reconstruction Center, Merit Health Central	Jackson	Mississippi
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	University of South Alabama Department of Surgery	Mobile	Alabama
United States	University Medical Center	New Orleans	Louisiana
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Arizona Burn Center at Maricopa Integrated Health Systems	Phoenix	Arizona
United States	Maine Medical Center	Portland	Maine
United States	University of California San Diego Regional Burn Center	San Diego	California
United States	Mercy General Burn Center - Springfield	Springfield	Missouri
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Avita Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing	> 95% epithelialization with a contiguous layer of viable epithelium	Wound healing assessed at all study visits