Full-thickness Skin DefectsNCT04091672
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A study testing Investigational Intervention (RECELL + more widely meshed autograft) in people with Full-thickness Skin Defects and Degloving Injuries, run by Avita Medical at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries
- What is being tested?
- Investigational Intervention (RECELL + more widely meshed autograft)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 18 sitesUnited States
- Study dates
- 2 Mar 2020to 2 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Cook County Health
Chicago, Illinois, 60612
Ohio State University
Columbus, Ohio, 43210
Duke University Hospital
Durham, North Carolina, 27710
JPS Health Network
Fort Worth, Texas, 76104
Kendall Regional Medical Center
Miami, Florida, 33175
University Medical Center
New Orleans, Louisiana, 70112
University of Rochester Medical Center
New York, New York, 14642
UCI Medical Center
Orange, California, 92868
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Temple University
Philadelphia, Pennsylvania, 19140
Arizona Burn Center - Valleywise Health
Phoenix, Arizona, 85008
Rhode Island Hospital
Providence, Rhode Island, 02903
Metis Foundation
San Antonio, Texas, 78216
Lundquist Institute @Harbor UCLA
Torrance, California, 90502
University of Arizona - Banner Health
Tucson, Arizona, 85719
Carle Foundation Hospital
Urbana, Illinois, 61801
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin, Surgical Wound, Skin Cancer
- Being tested
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Medical subject headings
- Degloving Injuries, Crush Injuries, Surgical Wound, Skin Neoplasms, Cellulitis, Infections, Fasciitis, Necrotizing, Wounds, Gunshot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Intervention (Conventional Autograft)Procedure or surgery
Also called meshed split-thickness skin graft
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
Investigational Intervention (RECELL + more widely meshed autograft)Device
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)
| Study group | Role | What they receive |
|---|---|---|
| All Participants (within patient control) | Experimental | 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. Receives: Procedure: Control Intervention (Conventional Autograft); Device: Investigational Intervention (RECELL + more widely meshed autograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Treatment Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start2 Mar 2020
- Primary completion7 Mar 2022
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full-thickness Skin DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091672
- Sponsor's protocol ID
- CTP007
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2019
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 38098145
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04091672
- Acronym / sponsor ID
- CTP007
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin, Surgical Wound, Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants (within patient control) | Experimental | Procedure: Control Intervention (Conventional Autograft), Device: Investigational Intervention (RECELL + more widely meshed autograft)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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Intervention (Conventional Autograft)Also: meshed split-thickness skin graftMeshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™) | Procedure or surgery | All Participants (within patient control) |
| 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™) | Device | All Participants (within patient control) |
Primary outcome
Incidence of Treatment Area Healing
Time frame: Prior to or at 8 weeks
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
Time frame: Treatment Day
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38098145Henry 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.
Related trials for Full-thickness Skin Defects
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
RecruitingObservational study
Clinical and Histological Study of a Novel Dermal Substitute
Skin Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Intervention (RECELL + more widely meshed autograft) in people with Full-thickness Skin Defects and Degloving Injuries, run by Avita Medical at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Area Healing (time frame: Prior to or at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.