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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Intervention (Conventional Autograft) | Procedure | Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™) |
|
| 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 |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center - Valleywise Health | Phoenix | Arizona | 85008 | United States | ||
| University of Arizona - Banner Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38098145 | Derived | 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. |
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The design of this study is a within-patient comparison. Protocol enrollment is 65 (participants), with 130 interventions (2 per participant).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Intervention | After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2020 |
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The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
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| 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™) |
|
| 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 |
| FG001 | Investigational Intervention (RECELL) | After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings). |
| COMPLETED |
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| NOT COMPLETED |
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Experimental: All Participants (within patient control)
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: All Participants (Within Patient Control) | All subjects will receive both RECELL and skin graft. Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol | Posted | Count of Units | Treatment Areas | Prior to or at 8 weeks | Treatment Areas | Treatment Areas |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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). | ITT | Posted | Mean | Standard Deviation | Expansion Ratio | Treatment Day | Study Areas | Study Areas |
|
26 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Intervention | After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings) | 6 | 65 | 2 | 65 | 35 | 65 |
| EG001 | Investigational Intervention (RECELL) | After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings). | 6 | 65 | 2 | 65 | 33 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired Healing | General disorders | Systematic Assessment |
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| Local Soft Tissue Infection | Infections and infestations | Systematic Assessment |
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| Other Infection | Infections and infestations | Systematic Assessment |
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| Graft Loss | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin Graft Failure | Injury, poisoning and procedural complications | Systematic Assessment |
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| Suture Related Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Device Malfunction | Product Issues | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired Healing | General disorders | Non-systematic Assessment |
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| Local Soft Tissue Infection | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Graft Loss | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin Graft Failure | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin Graft Scar Contracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Soft Tissue Foreign body | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Decomposition | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Necrosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Secretion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Excessive Granulation Tissue | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin Exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP Global Clinical Research | AVITA Medical | 1-833-462-8482 | ekirshner@avitamedical.com |
| Jul 9, 2024 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000069836 | Degloving Injuries |
| D000071576 | Crush Injuries |
| D000072836 | Surgical Wound |
| D012878 | Skin Neoplasms |
| D002481 | Cellulitis |
| D007239 | Infections |
| D019115 | Fasciitis, Necrotizing |
| D014948 | Wounds, Gunshot |
| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D014950 | Wounds, Penetrating |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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