BurnsNCT03626701
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
A study testing RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing and Conventional autografting (only when indicated) in people with Burns, run by Avita Medical at 9 sites in United States.
Trial summary
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Burns
- What is being tested?
- RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing and Conventional autografting (only when indicated)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Mar 2020to 3 Jun 2022
- 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 partial-thickness thermal burn injury.
- The patient has a thermal burn injury that is:
- ≤ 30% TBSA (exclusive of superficial areas) and
- ≤ 10% of the burn injury TBSA is a full-thickness burn.
- The Index Burn must be a clean partial-thickness burn injury > or = to 160 cm2 and between 2-20% BSA (inclusive).
- The Index Burn may not cover the face, hand, foot or perineum/genitalia (Note: a patient with wounds in these areas may be enrolled but the Index Burn Area may not include these areas).
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- The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule.
- The patient and/or parent/guardian agrees to abstain from any other treatment for closure of the Index Burn for the duration of the study, unless medically necessary.
- The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- 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,
- Understand instruction, and
- Provide voluntary informed written consent/assent as appropriate for study participation.
Who cannot join
- Not able to understand English or Spanish.
- Burns caused by chemicals, electricity or radiation.
- Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
- Burn injury has had prior treatment for definitive closure.
- Patients for whom use of sedation/general anesthesia is not medically appropriate.
- Superficial/trivial burns or burns that in the investigator's opinion appear to be healing sufficiently such that care under this protocol would be inappropriate.
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- Patient requires immediate or staged surgical procedures for closure of their partial-thickness burns.
- Conditions, e.g., previous burn injury to study area, poor nutritional status, poorly controlled diabetes mellitus (HbA1c >9%), that in the investigator's opinion may compromise subject safety or trial objectives.
- Current use of medications, e.g., immunosuppressive agents (excluding inhaled corticosteroids), that in the investigator's opinion may compromise subject safety or trial objectives.
- Inhalation injury.
- Active infection, cellulitis or need for immediate grafting at the planned treatment areas.
- Concerns for parent/guardian's ability to provide appropriate follow-up care.
- Subjects with a known hypersensitivity to trypsin or compound sodium lactate for irrigation solution.
- Subjects with a known sensitivity to silver.
- In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- Immediate life-threatening condition or life expectancy less than one year.
- Previous randomization within this investigation.
- Post-Randomization Inclusion Criteria (prior to treatment):
- Patient randomized (and will be treated) within 72 hours from the time of the burn injury.
- Patient continues to meet all pre-randomization inclusion criteria.
- Post-Randomization Exclusion Criteria (prior to treatment):
- 1. Incidental finding of any pre-randomization exclusion criteria.
- Consented subjects who do not meet the post-randomization eligibility criteria and did not receive study treatment will be followed through the Day 28 visit and then withdrawn from the study. The criteria for which exclusion was based will be documented.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of North Carolina
Chapel Hill, North Carolina, 27599-7600
Medical University of South Carolina
Charleston, South Carolina, 29425
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Arizona Burn Center / Valleywise Health
Phoenix, Arizona, 85008
Evan Hayes Burn Center, Virginia Commonwealth University
Richmond, Virginia, 23219
University of Washington Regional Burn Center at Harborview Medical Center
Seattle, Washington, 98104
University of South Florida Tampa General Hospital
Tampa, Florida, 33606
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
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 Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
- Conditions
- Burns
- Being tested
- RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing, Conventional autografting (only when indicated)
- Keywords
- Pediatric, Burns, Partial-thickness
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting DeviceDevice
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Mepilex® Ag Wound DressingCombination product
Application of Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)Procedure or surgery
When indicated, conventional autografting in accordance with Investigator's standard practice
| Study group | Role | What they receive |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Experimental | RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated) Receives: Device: RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device; Procedure: Conventional autografting (only when indicated) |
| Mepilex® Ag Wound Dressing | Active comparator | Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated) Receives: Combination Product: Mepilex® Ag Wound Dressing; Procedure: Conventional autografting (only when indicated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Index Burns With Day 10 Healing
Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
Measured: 10 Days post-treatment
Secondary outcomes (2)
Incidence of Day 21 Healing of the Index Burn
Incidence of Day 21 healing of the Index Burn confirmed on Day 28
Measured: Day 21, confirmed on Day 28
Incidence of Conventional Autografting to Achieve Healing of the Index Burn
Incidence of conventional autografting to achieve healing of the Index Burn
Measured: Through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start3 Mar 2020
- Primary completion23 Jun 2021
- Study completion3 Jun 2022
Why it stopped: In June 2021, the US FDA approved expanded use of the RECELL System for treatment of acute full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age).
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 BurnsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 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
- NCT03626701
- Sponsor's protocol ID
- CTP006-2
- Other IDs
- RESTORE KIDS
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2018
- Last updated
- 30 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 30 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 Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)
- ClinicalTrials.gov ID
- NCT03626701
- Acronym / sponsor ID
- CTP006-2
- Conditions
- Burns
- Keywords
- Pediatric, Burns, Partial-thickness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In June 2021, the US FDA approved expanded use of the RECELL System for treatment of acute full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age).
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RECELL® Autologous Cell Harvesting Device | Experimental | Device: RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Procedure: Conventional autografting (only when indicated)RECELL + Telfa™ Clear and Xeroform™ dressings Conventional autografting (only when indicated) |
| Mepilex® Ag Wound Dressing | Active comparator | Combination Product: Mepilex® Ag Wound Dressing, Procedure: Conventional autografting (only when indicated)Mepilex® Ag Wound Dressing Conventional autografting (only when indicated) |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male or female patients aged 1 through 16 years (inclusive) with a partial-thickness thermal burn injury.
- The patient has a thermal burn injury that is:
- The Index Burn must be a clean partial-thickness burn injury > or = to 160 cm2 and between 2-20% BSA (inclusive).
- The Index Burn may not cover the face, hand, foot or perineum/genitalia (Note: a patient with wounds in these areas may be enrolled but the Index Burn Area may not include these areas).
- The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule.
Key exclusion criteria (23 listed)
- Not able to understand English or Spanish.
- Burns caused by chemicals, electricity or radiation.
- Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
- Burn injury has had prior treatment for definitive closure.
- Patients for whom use of sedation/general anesthesia is not medically appropriate.
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 |
|---|---|---|
| RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting DeviceApplication 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 |
| Mepilex® Ag Wound DressingApplication of Mepilex® Ag Wound Dressing | Combination product | Mepilex® Ag Wound Dressing |
| Conventional autografting (only when indicated)When indicated, conventional autografting in accordance with Investigator's standard practice | Procedure or surgery | Mepilex® Ag Wound Dressing, RECELL® Autologous Cell Harvesting Device |
Primary outcome
Incidence of Index Burns With Day 10 Healing
Time frame: 10 Days post-treatment
Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
2 secondary outcomes
Incidence of Day 21 Healing of the Index Burn
Time frame: Day 21, confirmed on Day 28
Incidence of Conventional Autografting to Achieve Healing of the Index Burn
Time frame: Through Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing and Conventional autografting (only when indicated) in people with Burns, run by Avita Medical at 9 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 13 inclusion and 23 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 30 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 9 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 26 Jun 2023). 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?
Incidence of Index Burns With Day 10 Healing (time frame: 10 Days post-treatment). 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 30 Jul 2024.