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

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.

Study Overview

• Status: Completed
• Conditions: Cellulitis; Surgical Wound; Skin Cancer; Infection; Crush Injuries; Degloving Injuries; Gun Shot Wound; Necrotizing Fasciitis; Laceration of Skin; Full-thickness Skin Defects
• Intervention / Treatment: Procedure: Control Intervention (Conventional Autograft); Device: Investigational Intervention (RECELL + more widely meshed autograft)

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center - Valleywise Health
    • Tucson, Arizona, United States, 85719
      • University of Arizona - Banner Health
  • California
    • Orange, California, United States, 92868
      • UCI Medical Center
    • Torrance, California, United States, 90502
      • Lundquist Institute @Harbor UCLA
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Miami, Florida, United States, 33175
      • Kendall Regional Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Cook County Health
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center
  • New York
    • New York, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network
    • San Antonio, Texas, United States, 78216
      • Metis Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Participants (within patient control); 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); Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™); Other Names: meshed split-thickness skin graft; 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™)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
POSAS (Patient and Observer Scar Assessment Scale)	Blinded evaluator and subject overall opinion score (1-10), where 10 corresponds to the worst imaginable scar	At weeks 26, 36 and 52
Subject Treatment Preference	Subjects will be asked to specify which treatment region they are more satisfied with (A or B)	At week 52
Investigator Treatment Preference	Investigators will be asked to specify which treatment region they are more satisfied with (A or B)	At week 52

Collaborators and Investigators

• Sponsor: Avita Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Musculoskeletal Diseases; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Soft Tissue Injuries; Wounds, Penetrating; Wounds and Injuries; Cellulitis; Surgical Wound; Fasciitis; Crush Injuries; Degloving Injuries; Lacerations; Wounds, Gunshot; Fasciitis, Necrotizing
• Other Study ID Numbers: CTP007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes