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
1 other identifier
interventional
65
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedStudy Start
First participant enrolled
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedJuly 30, 2024
July 1, 2024
2 years
September 13, 2019
July 24, 2023
July 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
All Participants (within patient control)
EXPERIMENTALEach 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.
Interventions
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avita Medicallead
Study Sites (18)
Arizona Burn Center - Valleywise Health
Phoenix, Arizona, 85008, United States
University of Arizona - Banner Health
Tucson, Arizona, 85719, United States
UCI Medical Center
Orange, California, 92868, United States
Lundquist Institute @Harbor UCLA
Torrance, California, 90502, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Kendall Regional Medical Center
Miami, Florida, 33175, United States
Cook County Health
Chicago, Illinois, 60612, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
University Medical Center
New Orleans, Louisiana, 70112, United States
University of Rochester Medical Center
New York, New York, 14642, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Ohio State University
Columbus, Ohio, 43210, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
Metis Foundation
San Antonio, Texas, 78216, United States
Related Publications (1)
Henry S, Mapula S, Grevious M, Foster KN, Phelan H, Shupp J, Chan R, Harrington D, Mashruwala N, Brown DA, Mir H, Singer G, Cordova A, Rae L, Chin T, Castanon L, Bell D, Hughes W, Molnar JA. Maximizing wound coverage in full-thickness skin defects: A randomized-controlled trial of autologous skin cell suspension and widely meshed autograft versus standard autografting. J Trauma Acute Care Surg. 2024 Jan 1;96(1):85-93. doi: 10.1097/TA.0000000000004120. Epub 2023 Sep 1.
PMID: 38098145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- SVP Global Clinical Research
- Organization
- AVITA Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2019
First Posted
September 17, 2019
Study Start
March 2, 2020
Primary Completion
March 7, 2022
Study Completion
February 2, 2023
Last Updated
July 30, 2024
Results First Posted
September 21, 2023
Record last verified: 2024-07