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

Not Applicable

Completed

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

Interventions: Procedure: Control Intervention (Conventional Autograft)
Device: Investigational Intervention (RECELL + more widely meshed autograft)

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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:
1. Understand the full nature and purpose of the study, including possible risks and adverse events,
2. Understand instructions, and
3. Provide voluntary informed written consent.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
All Participants (within patient control)	Control Intervention (Conventional Autograft)	Each participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a full-thickness skin defect.
All Participants (within patient control)	Investigational Intervention (RECELL + more widely meshed autograft)	Each participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a full-thickness skin defect.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Area Healing	Prior to or at 8 weeks	The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.
Donor Skin Area to Treatment Area Expansion Ratio	Treatment Day	The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).

Secondary Outcome Measures

Name	Time	Method

Locations (18): Cook County Health
🇺🇸
Chicago, Illinois, United States
Ohio State University
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Columbus, Ohio, United States
Kendall Regional Medical Center
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Miami, Florida, United States
University of Rochester Medical Center
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New York, New York, United States
Duke University Hospital
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Durham, North Carolina, United States
UCI Medical Center
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Orange, California, United States
Lundquist Institute @Harbor UCLA
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Torrance, California, United States
Arizona Burn Center - Valleywise Health
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Phoenix, Arizona, United States
University of Arizona - Banner Health
🇺🇸
Tucson, Arizona, United States
MedStar Washington Hospital Center
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Washington, District of Columbia, United States
Carle Foundation Hospital
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Urbana, Illinois, United States
JPS Health Network
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Fort Worth, Texas, United States
Temple University
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Philadelphia, Pennsylvania, United States
Metis Foundation
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San Antonio, Texas, United States
University Medical Center
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New Orleans, Louisiana, United States
Wake Forest University Health Sciences
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Winston-Salem, North Carolina, United States
Thomas Jefferson University
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Philadelphia, Pennsylvania, United States
Rhode Island Hospital
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Providence, Rhode Island, United States