Skin; DeformityNCT03624192
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
A study testing RECELL® Autologous Cell Harvesting Device and Telfa™ Clear and Xeroform™ dressings in people with Skin; Deformity, run by Avita Medical at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Skin; Deformity
- What is being tested?
- RECELL® Autologous Cell Harvesting Device and Telfa™ Clear and Xeroform™ dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Sep 2018to 13 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Understand the full nature and purpose of the study, including possible risks and adverse events, and
Show all 11Show fewer
- Provide informed consent/assent as appropriate for study participation.
- 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.
Who cannot join
- Prior autograft harvest at planned study donor sites.
- Patients with sepsis or hemodynamic instability.
- The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
- Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
- The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
- Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
- In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Akron Children's Hospital
Akron, Ohio, 44308
Shriners Hospital for Children, Boston
Boston, Massachusetts, 02114
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Arizona Burn Center at Maricopa Intergrated Health Systems
Phoenix, Arizona, 85008
Shriners Hospital for Children, Northern California
Sacramento, California, 95817
University of California at San Diego
San Diego, California, 92103
University of Washington Regional Burn Center at Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)
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.
- Conditions
- Skin; Deformity
- Being tested
- RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings
- Keywords
- Pediatric, Complex Skin Deformities
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECELL® Autologous Cell Harvesting DeviceDevice
Also called RES (Regenerative Epidermal Suspension)
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™ dressingsOther
Also called Control
Telfa™ Clear and Xeroform™ dressings
| Study group | Role | What they receive |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Experimental | RECELL + Telfa™ Clear and Xeroform™ dressings Receives: Device: RECELL® Autologous Cell Harvesting Device |
| Telfa™ Clear and Xeroform™ dressings | Active comparator | Telfa™ Clear and Xeroform™ dressings Receives: Other: Telfa™ Clear and Xeroform™ dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 weeks
Secondary outcomes (6)
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)
Measured: 4 weeks
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
Physician will be asked which donor site (A or B) they prefer
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start19 Sep 2018
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Why it stopped: Study closed in response to COVID-19 and overall program objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin; DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject serves as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624192
- Sponsor's protocol ID
- CTP006-1
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2018
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)
- ClinicalTrials.gov ID
- NCT03624192
- Acronym / sponsor ID
- CTP006-1
- Conditions
- Skin; Deformity
- Keywords
- Pediatric, Complex Skin Deformities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed in response to COVID-19 and overall program objectives.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 28 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Experimental | Device: RECELL® Autologous Cell Harvesting DeviceRECELL + Telfa™ Clear and Xeroform™ dressings |
| Telfa™ Clear and Xeroform™ dressings | Active comparator | Other: Telfa™ Clear and Xeroform™ dressingsTelfa™ Clear and Xeroform™ dressings |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (8 listed)
- Prior autograft harvest at planned study donor sites.
- Patients with sepsis or hemodynamic instability.
- The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
- Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
- The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECELL® Autologous Cell Harvesting DeviceAlso: RES (Regenerative Epidermal Suspension)Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings | Device | RECELL® Autologous Cell Harvesting Device |
| Telfa™ Clear and Xeroform™ dressingsAlso: ControlTelfa™ Clear and Xeroform™ dressings | Other | Telfa™ Clear and Xeroform™ dressings |
Primary outcome
Time to Complete Closure
Time frame: 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.
6 secondary outcomes
Donor Site Treatment Preference (Site A or Site B) Reported by Subject
Time frame: 4 weeks
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
Time frame: 4 weeks
Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
Time frame: Day 7
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
Time frame: Day 7 or 8
Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Week 24
Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECELL® Autologous Cell Harvesting Device and Telfa™ Clear and Xeroform™ dressings in people with Skin; Deformity, run by Avita Medical at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Closure (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.