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

Primary Purpose

Full-thickness Skin Defects, Degloving Injuries, Crush Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Intervention (Conventional Autograft)
Investigational Intervention (RECELL + more widely meshed autograft)
Sponsored by
Avita Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full-thickness Skin Defects

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Burn Center - Valleywise Health
  • University of Arizona - Banner Health
  • UCI Medical Center
  • Lundquist Institute @Harbor UCLA
  • MedStar Washington Hospital Center
  • Kendall Regional Medical Center
  • Cook County Health
  • Carle Foundation Hospital
  • University Medical Center
  • University of Rochester Medical Center
  • Duke University Hospital
  • Wake Forest University Health Sciences
  • Ohio State University
  • Thomas Jefferson University
  • Temple University
  • Rhode Island Hospital
  • JPS Health Network
  • Metis Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants (within patient control)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
September 18, 2023
Sponsor
Avita Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04091672
Brief Title
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avita Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin, Surgical Wound, Skin Cancer, Cellulitis, Infection, Necrotizing Fasciitis, Gun Shot Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants (within patient control)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control Intervention (Conventional Autograft)
Other Intervention Name(s)
meshed split-thickness skin graft
Intervention Description
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
Intervention Type
Device
Intervention Name(s)
Investigational Intervention (RECELL + more widely meshed autograft)
Intervention Description
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)
Primary Outcome Measure Information:
Title
Incidence of Treatment Area Healing
Description
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.
Time Frame
Prior to or at 8 weeks
Title
Donor Skin Area to Treatment Area Expansion Ratio
Description
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).
Time Frame
Treatment Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Arizona Burn Center - Valleywise Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
University of Arizona - Banner Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lundquist Institute @Harbor UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Kendall Regional Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Cook County Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Rochester Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Metis Foundation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78216
Country
United States

12. IPD Sharing Statement

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

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