RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
NCT ID: NCT04091672
Last Updated: 2024-07-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
65 participants
INTERVENTIONAL
2020-03-02
2023-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
NCT02380612
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
NCT03624192
CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
NCT02994654
Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
NCT02992249
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
NCT01138917
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Control Intervention (Conventional Autograft)
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
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™)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Control Intervention (Conventional Autograft)
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
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™)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avita Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Burn Center - Valleywise Health
Phoenix, Arizona, United States
University of Arizona - Banner Health
Tucson, Arizona, United States
UCI Medical Center
Orange, California, United States
Lundquist Institute @Harbor UCLA
Torrance, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Kendall Regional Medical Center
Miami, Florida, United States
Cook County Health
Chicago, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
University Medical Center
New Orleans, Louisiana, United States
University of Rochester Medical Center
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
JPS Health Network
Fort Worth, Texas, United States
Metis Foundation
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTP007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.