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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Royal Perth Hospital | OTHER |
| MedDRA Assistance Inc | UNKNOWN |
| BioStat International, Inc. |
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This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all participants | Experimental | All participants will receive both ReCell and split-thickness skin graft |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCell and Split-thickness skin graft | Device | The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) | Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was >=95% epithelialized. | 4 weeks |
| Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) | Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Epithelialization at Each Visit Through Week 16 | The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique. | Each visit through Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James H Holmes, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center at Maricopa Integrated Health Systems | Phoenix | Arizona | 85008 | United States | ||
| University of California Davis Regional Burn Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: All Participants (Within Patient Control) | Every subject received both interventions (RECELL and Control (2:1 meshed split-thickness autograft)). Two distinct but similar areas of burn injury at least 100 cm2 and second degree depth will be treated according to random assignment (Area A and Area B). One burn injury area receives RECELL (Investigational Treatment) and the other area Control (2:1 meshed autograft). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| INDUSTRY |
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| Wound Closure at Week 2 (Based on Investigators Assessment) | The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing. | Week 2 |
| Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) | Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional | Pain (Weeks 1-16) and Appearance (Weeks 16-52) |
| Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) | Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional. | Pain (Weeks 1-16) and Appearance (Weeks 16-52) |
| Sacramento |
| California |
| 95817 |
| United States |
| The Burn Center at Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Shands Burn Center at University of Florida | Gainesville | Florida | 32610 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital | Indianapolis | Indiana | 46202 | United States |
| NC Jaycee Burn Center at University of NC at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Tennessee Medical Center | Memphis | Tennessee | 38163 | United States |
| USAISR | Fort Sam Houston | Texas | 78234 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| Virginia Commonwealth University Health System- Evans Haynes Burn Center | Richmond | Virginia | 23298 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: All Participants (Within Patient Control) | Every subject received both interventions (RECELL and 2:1 meshed split-thickness autograft). Two distinct but similar areas of burn injury at least 100 cm2 and second degree depth will be treated according to random assignment (Area A and Area B). One burn injury area receives RECELL (Investigational Treatment) and the other area 2:1 meshed autograft (Control). |
| 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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| Race/Ethnicity, Customized | 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 | Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) | Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was >=95% epithelialized. | Analysis to evaluate non-inferiority of recipient site wound closure was performed on the ITT, PP, and MPP populations. | Posted | Count of Participants | Participants | 4 weeks |
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| Primary | Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) | Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis. | Analysis was performed on ITT, PP, and MPP populations. Note: The number of participants with evaluable donor sites differs than number of participants with evaluable recipient sites. | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Percent of Epithelialization at Each Visit Through Week 16 | The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique. | Percent Epithelialization presented for Per Protocol Population (PP) based on subjects presented for healing evaluation per visit | Posted | Mean | Standard Deviation | percentage of epithelialization | Each visit through Week 16 |
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| Secondary | Wound Closure at Week 2 (Based on Investigators Assessment) | The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing. | Posted | Count of Participants | Participants | Week 2 |
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| Secondary | Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) | Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional | Per-Protocol Population | Posted | Mean | Standard Deviation | Scores on a Scale (0-100) | Pain (Weeks 1-16) and Appearance (Weeks 16-52) |
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| Secondary | Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) | Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional. | Per-Protocol Population | Posted | Mean | Standard Deviation | Scores on a Scale (0-100) | Pain (Weeks 1-16) and Appearance (Weeks 16-52) |
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All adverse events occurring during the course of the clinical study were reported. Adverse event reporting was limited to wound findings, i.e. scarring, contraction, etc. of the study wound areas at Week 16 through to Week 52.
The number of specific adverse events that occurred per wound area is included in the Adverse Event Term Additional Description.
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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 | Experimental: All Participants (Within Patient Control) | All subjects received cell suspension prepared using the RECELL device applied to "RECELL Recipient Site" and 2:1 meshed conventional autografting applied to "Control Recipient Site" | 10 | 101 | 34 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea, Vomiting, Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Blood clot detected in left leg | Vascular disorders | Systematic Assessment |
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| Scar contracture release | Injury, poisoning and procedural complications | Systematic Assessment | Other wound |
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| >10% graft loss | Injury, poisoning and procedural complications | Systematic Assessment | RECELL Recipient Site |
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| Burn wound excision/grafting | Injury, poisoning and procedural complications | Systematic Assessment | Other wound |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| New burn injury | Injury, poisoning and procedural complications | Systematic Assessment | RECELL Recipient Site |
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| New burn injury | Injury, poisoning and procedural complications | Systematic Assessment | Control Recipient Site |
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| Suspected wound infection | Infections and infestations | Systematic Assessment | RECELL Recipient Site |
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| Graft failure conversion to full thickness wound | Injury, poisoning and procedural complications | Systematic Assessment | RECELL Recipient Site |
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| Coumadin toxicity | Injury, poisoning and procedural complications | Systematic Assessment |
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| Worsening anemia post-operatively | Blood and lymphatic system disorders | Systematic Assessment |
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| Intraoperative tachycardia resolved with fluids and beta-blockade | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertrophic Scar | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL Recipient Site (n=10) Control Recipient Site (n=6) Other (n=11) |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL Recipient Site (n=3) Control Recipient Site ((n=1) Other (n=2) |
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| Hypergranulated Tissue/Hypergranulation | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL Recipient Site (n=8) Control Recipient Site (n=1) Other (n=1) |
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| Itching/Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL Recipient Site (n=5) Control Recipient site (n=5) Other (n=4) |
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| Hypertrophy | General disorders | Systematic Assessment | RECELL Recipient Site (n=5) Control Recipient Site (n=3) Other (n=5) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | AVITA Medical | 661-367-9170 | clinicaltrial@avitamedical.com |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Asian |
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| American Indian |
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| Black |
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| Other |
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| Modified Per Protocol Population (MPP) |
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| Intent to Treat (ITT) |
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