RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Completed · Not applicable

Conditions studied: Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin, Surgical Wound, Skin Cancer, Cellulitis, Infection, Necrotizing Fasciitis, Gun Shot Wound

In brief

A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.

Key facts

Study ID

NCT04091672

Run by

Avita Medical

People needed

65

Starts

2020-03-02

Expected to finish

2023-02-02

Last updated by the study team

2024-07-30

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
• The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
• Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
• The patient is at least 5 years of age.
• The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
• The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
• The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
• In the opinion of the investigator, the patient and/or guardian must be able to:
• Understand the full nature and purpose of the study, including possible risks and adverse events,
• Understand instructions, and
• Provide voluntary informed written consent.

You may not qualify if…

• Not able to understand English or Spanish.
• The area requiring autografting sustained a burn injury.
• The treatment area has previously failed to heal subsequent to surgical intervention for closure.
• The patient is unable to follow the protocol requirements.
• The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.
• Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.
• The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
• The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
• Life expectancy is less than 1 year.

Where it is running

• Arizona Burn Center - Valleywise Health — Phoenix, Arizona, United States
• University of Arizona - Banner Health — Tucson, Arizona, United States
• UCI Medical Center — Orange, California, United States
• Lundquist Institute @Harbor UCLA — Torrance, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Kendall Regional Medical Center — Miami, Florida, United States
• Cook County Health — Chicago, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• University Medical Center — New Orleans, Louisiana, United States
• University of Rochester Medical Center — New York, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• JPS Health Network — Fort Worth, Texas, United States
• Metis Foundation — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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