- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03333941
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85008
- Arizona Burn Center at Maricopa Integrated Health Systems
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70112
- University Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Tennessee
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Memphis, Tennessee, United States, 38103-3409
- University of Tennessee Health Science Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RES (Regenerative Epithelial Suspension)
|
RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP001-8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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