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

Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091672
• Other study ID #: CTP007
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: February 2, 2023

Study information

• Verified date: September 2023
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2, 2023
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

1. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).

2. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).

3. 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.

4. The patient is at least 5 years of age.

5. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.

6. 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).

7. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).

8. 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:

1. Not able to understand English or Spanish.

2. The area requiring autografting sustained a burn injury.

3. The treatment area has previously failed to heal subsequent to surgical intervention for closure.

4. The patient is unable to follow the protocol requirements.

5. The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.

6. Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.

7. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.

8. The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).

9. Life expectancy is less than 1 year.

Related Conditions & MeSH terms

• Cellulitis
• Crush Injuries
• Degloving Injuries
• Fasciitis
• Fasciitis, Necrotizing
• Full-thickness Skin Defects
• Gun Shot Wound
• Infection
• Laceration of Skin
• Lacerations
• Necrotizing Fasciitis
• Skin Cancer
• Surgical Wound
• Wounds and Injuries
• Wounds, Gunshot

Intervention

Procedure:
• Control Intervention (Conventional Autograft)
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)

Device:
• Investigational Intervention (RECELL + more widely meshed autograft)
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Avita Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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