Skin; Deformity
Conditions
Keywords
Pediatric, Complex Skin Deformities
Brief summary
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.
Interventions
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings
OTHERTelfa™ Clear and Xeroform™ dressings
Telfa™ Clear and Xeroform™ dressings
Sponsors
Biomedical Advanced Research and Development Authority
Avita Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Each subject serves as their own control.
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated. 2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive. 3. 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. 4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol. 5. In the opinion of the Investigator, the patient and/or parent/guardian must be able to: 1. Understand the full nature and purpose of the study, including possible risks and adverse events, and 2. Provide informed consent/assent as appropriate for study participation. 6. 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. 7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent. 9. Life expectancy greater than 52 weeks.
Exclusion criteria
1. Prior autograft harvest at planned study donor sites. 2. Patients with sepsis or hemodynamic instability. 3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas. 4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements. 5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives. 6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation. 7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). 8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Closure | up to 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Donor Site Treatment Preference (Site A or Site B) Reported by Physician | 4 weeks | Physician will be asked which donor site (A or B) they prefer |
| Donor Site Treatment Preference (Site A or Site B) Reported by Subject | 4 weeks | 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) |
| Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | Day 7 | Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment |
| Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | Day 7 or 8 | Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment |
| Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Week 24 | 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. |
| Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Week 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes | Up to Week 4 | 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 |
| Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites | Up to Week 4 | 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. |
| Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received | Week 4 and 24 | Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received |
| Mean Subject Reported Pain Score Before and After Dressing Changes | Up to Week 4 | 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. |
| Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation | Through Week 52 | Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Experimental: All Participants (Within Patient Control) All subjects receive both RECELL and Control. Each subject serves as their own control. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Experimental: All Participants (Within Patient Control) |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 3.7 Years STANDARD_DEVIATION 2.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: up to 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Time to Complete Closure | Subject 001 | 10 Days |
| RECELL | Time to Complete Closure | Subject 003 | 14 Days |
| RECELL | Time to Complete Closure | Subject 004 | 13 Days |
| Control | Time to Complete Closure | Subject 001 | 10 Days |
| Control | Time to Complete Closure | Subject 003 | 11 Days |
| Control | Time to Complete Closure | Subject 004 | 13 Days |
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.
Time frame: Week 24
Population: Data was not collected for subject 001
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 003 | 2 Score on a scale |
| RECELL | Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 004 | 2 Score on a scale |
| Control | Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 003 | 9 Score on a scale |
| Control | Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 004 | 3 Score on a scale |
| Unknown | Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 001 | — Score on a scale |
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
Time frame: Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | RECELL | 0 Participants |
| RECELL | Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | Control | 0 Participants |
| RECELL | Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | No difference/Can't tell | 3 Participants |
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
Time frame: Day 7 or 8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | RECELL | 0 Participants |
| RECELL | Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | Control | 0 Participants |
| RECELL | Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | No Pain at Either Donor SIte | 1 Participants |
| RECELL | Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | No Difference/Can't Tell | 2 Participants |
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
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Donor Site Treatment Preference (Site A or Site B) Reported by Physician | RECELL | 1 Physician Response |
| RECELL | Donor Site Treatment Preference (Site A or Site B) Reported by Physician | Control | 0 Physician Response |
| RECELL | Donor Site Treatment Preference (Site A or Site B) Reported by Physician | Unable to determine/no preference | 2 Physician Response |
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)
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Donor Site Treatment Preference (Site A or Site B) Reported by Subject | RECELL | 1 Participants |
| RECELL | Donor Site Treatment Preference (Site A or Site B) Reported by Subject | Control | 1 Participants |
| RECELL | Donor Site Treatment Preference (Site A or Site B) Reported by Subject | No Response | 1 Participants |
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.
Time frame: Week 24
Population: Data was not collected from subjects 001 and 004
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RECELL | Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 003 | 5 Score on a scale |
| Control | Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 003 | 10 Score on a scale |
| Unknown | Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 001 | — Score on a scale |
| Unknown | Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | Subject 004 | — Score on a scale |
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
Time frame: Week 4 and 24
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.
Time frame: Up to Week 4
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
Time frame: Through Week 52
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.
Time frame: Up to Week 4
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
Time frame: Up to Week 4