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Study closed in response to COVID-19 and overall program objectives.
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Experimental | RECELL + Telfa™ Clear and Xeroform™ dressings |
|
| Telfaâ„¢ Clear and Xeroformâ„¢ dressings | Active Comparator | Telfaâ„¢ Clear and Xeroformâ„¢ dressings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Device | Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Closure | The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits. | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Donor Site Treatment Preference (Site A or Site B) Reported by Subject | Subject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked) | 4 weeks |
| Donor Site Treatment Preference (Site A or Site B) Reported by Physician |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation | Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation | Through Week 52 |
| Mean Subject Reported Pain Score Before and After Dressing Changes |
Inclusion Criteria:
Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
In the opinion of the Investigator, the patient and/or parent/guardian must be able to:
The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
Life expectancy greater than 52 weeks.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center at Maricopa Intergrated Health Systems | Phoenix | Arizona | 85008 | United States | ||
Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.
RECELL + Telfaâ„¢ Clear and Xeroformâ„¢ dressings
RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings
Telfaâ„¢ Clear and Xeroformâ„¢ dressings: Telfaâ„¢ Clear and Xeroformâ„¢ dressings
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| ID | Title | Description |
|---|---|---|
| FG000 | RECELL | Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. RECELL + Telfa™ Clear and Xeroform™ dressings RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ 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, 2018 |
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Each subject serves as their own control.
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|
| Telfaâ„¢ Clear and Xeroformâ„¢ dressings | Other | Telfaâ„¢ Clear and Xeroformâ„¢ dressings |
|
|
Physician will be asked which donor site (A or B) they prefer |
| 4 weeks |
| Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment | Day 7 |
| Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment | Day 7 or 8 |
| Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar. | Week 24 |
| Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar. | Week 24 |
Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain. |
| Up to Week 4 |
| Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes | Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly | Up to Week 4 |
| Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites | Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain. | Up to Week 4 |
| Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received | Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received | Week 4 and 24 |
| Shriners Hospital for Children, Northern California |
| Sacramento |
| California |
| 95817 |
| United States |
| University of California at San Diego | San Diego | California | 92103 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Shriners Hospital for Children, Boston | Boston | Massachusetts | 02114 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| University of Washington Regional Burn Center at Harborview Medical Center | Seattle | Washington | 98104 | United States |
| FG001 | Control | very subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. RECELL + Telfa™ Clear and Xeroform™ dressings RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: All Participants (Within Patient Control) | All subjects receive both RECELL and Control. Each subject serves as their own control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Time to Complete Closure | The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits. | Posted | Number | Days | up to 4 weeks | Site | Site |
|
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Donor Site Treatment Preference (Site A or Site B) Reported by Subject | Subject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked) | Posted | Number | Participants | 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Donor Site Treatment Preference (Site A or Site B) Reported by Physician | Physician will be asked which donor site (A or B) they prefer | Posted | Number | Physician Response | 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment | Posted | Number | Participants | Day 7 |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment | Posted | Number | Participants | Day 7 or 8 |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar. | Data was not collected for subject 001 | Posted | Number | Score on a scale | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar. | Data was not collected from subjects 001 and 004 | Posted | Number | Score on a scale | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation | Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation | Not Posted | Through Week 52 | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Subject Reported Pain Score Before and After Dressing Changes | Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain. | Not Posted | Up to Week 4 | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes | Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly | Not Posted | Up to Week 4 | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites | Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain. | Not Posted | Up to Week 4 | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received | Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received | Not Posted | Week 4 and 24 | Participants |
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 | Experimental: All Participants (Within Patient Control) | Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. RECELL + Telfa™ Clear and Xeroform™ dressings RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings | 0 | 3 | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft Loss 135cm2 | Injury, poisoning and procedural complications | Systematic Assessment | Graft loss due to shearing of a non-study site |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Research | AVITA Medical | 661-367-9170 | USClinicalTrials@avitamedical.com |
| Jul 9, 2024 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown or Not Reported |
|
| 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 |
|
| Unknown or Not Reported |
|
| Subject 004 |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| RECELL |
| |||||
| Control |
| |||||
| Unable to determine/no preference |
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| Units | Counts |
|---|
| Participants |
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