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

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.

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Key information

Conditions

Full-thickness Skin Defects Cellulitis Connective Tissue Diseases Crush Injuries Degloving Injuries Fasciitis Fasciitis, Necrotizing Gun Shot Wound Infection Infections Inflammation Laceration of Skin Musculoskeletal Diseases Necrotizing Fasciitis Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Cancer Skin Diseases Skin Diseases, Infectious Skin Neoplasms Skin and Connective Tissue Diseases Soft Tissue Injuries Suppuration Surgical Wound Wounds and Injuries Wounds, Gunshot Wounds, Penetrating

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Burn Center - Valleywise Health, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Intervention (Conventional Autograft)

Procedure

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

Other names: meshed split-thickness skin graft

Investigational Intervention (RECELL + more widely meshed autograft)

Device

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

Primary outcomes

Incidence of Treatment Area Healing

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Avita Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Sep 17, 2019
Registry last updated: Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed