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The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReCell | Experimental | All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B |
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| Control | Experimental | All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCell | Device | The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample. The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas. | Prior to or at 8 weeks |
| Relative Reduction in Donor Skin Area Requirement | For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas. | Prior to or at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center at Maricopa Integrated Health Systems | Phoenix | Arizona | 85008 | United States | ||
| MedStar Washington Hospital Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: All Participants (Within Patient Control) | Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before the areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan). |
| 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 | Aug 25, 2016 |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103-3409 | United States |
| U.S.Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234-7767 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: All Participants (Within Patient Control) | All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated). |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas. | Per Protocol | Posted | Count of Participants | Participants | Prior to or at 8 weeks |
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| Primary | Relative Reduction in Donor Skin Area Requirement | For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas. | Intent-to-Treat Population | Posted | Geometric Mean | Standard Deviation | cm2 | Prior to or at 8 weeks |
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52 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 | All Participants | All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated). | 0 | 12 | 2 | 12 | 7 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failed Skin Graft | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
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| Delayed Wound Healing | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
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| Failed Skin Graft | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
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| Respiratory Distress | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failed Skin Graft | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
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| Delayed Wound Healing | General disorders | Systematic Assessment | RECELL |
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| Graft Loss Left Abdomen | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
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| Non-healing Burn Wound | General disorders | Systematic Assessment | RECELL |
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| Severe Intermittent Nerve Pain | Vascular disorders | Systematic Assessment | CONTROL |
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| Graft Loss Right Abdomen | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
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| Failed Skin Graft | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
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| Right Thigh Graft Loss | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
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| Graft Loss Left Upper Arm | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
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| Hypertrophic Scar | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Research | AVITA Medical | 661-367-9170 | USClinicalTrials@avitamedical.com |
| Jul 9, 2024 |
| Prot_SAP_002.pdf |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Unknown or Not Reported |
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