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Autologous Cell Therapy
RECELL® Autologous Cell Harvesting Device for Burns
N/A
Waitlist Available
Research Sponsored by Avita Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 10 and 28, weeks 16, 24, 36 and 52
Awards & highlights
Study Summary
This trial is testing whether a new treatment for burns can help them heal better and faster than the current standard.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 10 and 28, weeks 16, 24, 36 and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10 and 28, weeks 16, 24, 36 and 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Index Burns With Day 10 Healing
Secondary outcome measures
Incidence of Conventional Autografting to Achieve Healing of the Index Burn
Incidence of Day 21 Healing of the Index Burn
Other outcome measures
Absolute area (cm2) of Index Burn requiring autografting
BOQ Outcomes (raw scores and recovery curves for all domains), with baseline at Day 10
Health economics / medical resource utilization
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RECELL® Autologous Cell Harvesting DeviceExperimental Treatment2 Interventions
RECELL + Telfa™ Clear and Xeroform™ dressings
Conventional autografting (only when indicated)
Group II: Mepilex® Ag Wound DressingActive Control2 Interventions
Mepilex® Ag Wound Dressing
Conventional autografting (only when indicated)
Find a Location
Who is running the clinical trial?
Avita MedicalLead Sponsor
15 Previous Clinical Trials
631 Total Patients Enrolled
5 Trials studying Burns
319 Patients Enrolled for Burns
Biomedical Advanced Research and Development AuthorityFED
81 Previous Clinical Trials
909,422 Total Patients Enrolled
3 Trials studying Burns
166 Patients Enrolled for Burns
Frequently Asked Questions
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