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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

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

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


Participation Criteria
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Eligibility Criteria
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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: Understand the full nature and purpose of the study, including possible risks and adverse events, Understand instructions, and 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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants (within patient control)<br>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. | Procedure: Control Intervention (Conventional Autograft)<br>* Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)<br>* Other names: meshed split-thickness skin graft;Device: Investigational Intervention (RECELL + more widely meshed autograft)<br>* More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Area Healing | 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. | Prior to or at 8 weeks | 
| Donor Skin Area to Treatment Area Expansion Ratio | 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). | Treatment Day |