Infections

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Soft Tissue Injuries

Wounds, Penetrating

Necrotizing Fasciitis

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.

Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)

Control Intervention (Conventional Autograft)

More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)

Investigational Intervention (RECELL + more widely meshed autograft)

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.

The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).

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

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

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.

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).

Avita Medical

After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control).

Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)

Control Intervention

After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention.

RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).

Investigational Intervention (RECELL)

All subjects will receive both RECELL and skin graft. Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction	NCT04091672	Full-thickness ... Degloving Injur... Crush Injuries Laceration of S... Surgical Wound Skin Cancer Cellulitis Infection Necrotizing Fas... Gun Shot Wound	Control Interve... Investigational...	5 Years -	Avita Medical
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction	NCT04091672	Full-thickness ... Degloving Injur... Crush Injuries Laceration of S... Surgical Wound Skin Cancer Cellulitis Infection Necrotizing Fas... Gun Shot Wound	Control Interve... Investigational...	5 Years -	Avita Medical

Spots Global Cancer Trial Database for necrotizing fasciitis