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

Completed

• 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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Primary Completion: 2019-05
• Study Completion: 2020-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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

Trial Locations

Locations (22)

University of South Alabama Department of Surgery; 🇺🇸 Mobile, Alabama, United States

Arizona Burn Center at Maricopa Integrated Health Systems; 🇺🇸 Phoenix, Arizona, United States

University of California San Diego Regional Burn Center; 🇺🇸 San Diego, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Joseph M Still Research Foundation; 🇺🇸 Augusta, Georgia, United States

Richard M. Fairbanks Burn Center at Eskenazi Health; 🇺🇸 Indianapolis, Indiana, 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

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