BurnsNCT03333941
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
An observational study of Burns, run by Avita Medical at 6 sites in United States.
Trial summary
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Burns
- What is being tested?
- ReCell® Autologous Cell Harvesting Device
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Oct 2017to 8 May 2019
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Burn Unit
Who may be able to join
- The subject requires skin grafting as a result of an acute thermal burn injury (i.e., injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
- The area of total burn injury is 5-50% TBSA inclusive.
- Area(s) requiring skin grafting at least 320 square centimeters.
- The subject is at least 5 years of age.
- The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
- The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
- The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
Who cannot join
- The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
- The subject is unable to follow the protocol.
- The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
- The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
- Pregnant or lactating women.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Tennessee Health Science Center
Memphis, Tennessee, 38103-3409
University Medical Center
New Orleans, Louisiana, 70112
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, 85008
Tampa General Hospital
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Continued Access Protocol: A Prospective, Multicenter, Single-Arm, Observational Study of the Safety and Clinical Performance of RES (Regenerative Epithelial Suspension) Prepared With the ReCell® Device Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.
Read the detailed description
Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. Healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning the clinical performance and safety of the ReCell device will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.
Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this study at up to 15 institutions.
It is anticipated that enrollment will continue until PMA approval. Subject follow-up will continue until the last enrolled subject completes the 24-week visit.
- Conditions
- Burns
- Being tested
- ReCell® Autologous Cell Harvesting Device
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCell® Autologous Cell Harvesting DeviceDevice
RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
| Study group | Role | What they receive |
|---|---|---|
| RES (Regenerative Epithelial Suspension) | Not described Receives: Device: ReCell® Autologous Cell Harvesting Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Wound Healing
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
Measured: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start26 Oct 2017
- Primary completion19 Dec 2018
- Study completion8 May 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333941
- Sponsor's protocol ID
- CTP001-8
- Status last verified
- Jul 2024
- First submitted
- 25 Oct 2017
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
- Continued Access Protocol: A Prospective, Multicenter, Single-Arm, Observational Study of the Safety and Clinical Performance of RES (Regenerative Epithelial Suspension) Prepared With the ReCell® Device Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
- ClinicalTrials.gov ID
- NCT03333941
- Acronym / sponsor ID
- CTP001-8
- Conditions
- Burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 19 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.
Detailed description
Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. Healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning the clinical performance and safety of the ReCell device will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.
Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this study at up to 15 institutions.
It is anticipated that enrollment will continue until PMA approval. Subject follow-up will continue until the last enrolled subject completes the 24-week visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RES (Regenerative Epithelial Suspension) | – | Device: ReCell® Autologous Cell Harvesting Device |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Burn Unit
Key inclusion criteria (8 listed)
- The subject requires skin grafting as a result of an acute thermal burn injury (i.e., injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
- The area of total burn injury is 5-50% TBSA inclusive.
- Area(s) requiring skin grafting at least 320 square centimeters.
- The subject is at least 5 years of age.
- The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
Key exclusion criteria (5 listed)
- The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
- The subject is unable to follow the protocol.
- The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
- The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
- Pregnant or lactating women.
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 DeviceRES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. | Device | RES (Regenerative Epithelial Suspension) |
Primary outcome
Percentage of Participants With Wound Healing
Time frame: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
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.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Avita Medical at 6 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 8 inclusion and 5 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: finished, 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 6 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 19 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?
Percentage of Participants With Wound Healing (time frame: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)). 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.