Integra®-SC for Burns
Phase-Based Progress Estimates
Effectiveness
Safety
Sunnybrook Health Sciences Centre, Toronto, Canada
Burns
Integra®-SC - DeviceEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing whether combining stem cells with an existing skin substitute can improve wound healing for burn patients. Integra®-SC is a treatment for burns that is free of charge. This treatment has been previously approved by the FDA for a different condition. There will be no patients in this trial that will receive a placebo.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 9 Secondary · Reporting Duration: Discharge to 1 year post-discharge
Month 4
Quality of skin regeneration - Abnormal scar formation
Quality of skin regeneration - Arterial bleeding from the wound site
Quality of skin regeneration - Detachment of Integra®-SC
Quality of skin regeneration - Signs of wound infection
Safety - Number of participants with non-healing wounds
Safety - Number of participants with surgical site infections
Time of wound healing
Year 1
Scar Formation - Vascularity of the healed area
Scar formation - Height of the healed area
Scar formation - Pigmentation of the healed area
Scar formation - Pliability of the healed area
Year 1
Safety - Number of patients with poor scarring requiring additional (unplanned) operation
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Integra®-SC
1 of 2
Active Control
Experimental Treatment
24 Total Participants · 2 Treatment Groups
Primary Treatment: Integra®-SC · No Placebo Group · Phase 1
Integra®-SC
Device
Experimental Group · 1 Intervention: Integra®-SC · Intervention Types: DeviceControl
Device
ActiveComparator Group · 1 Intervention: Integra® · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: discharge to 1 year post-discharge
Closest Location: Sunnybrook Health Sciences Centre · Toronto, Canada
2007First Recorded Clinical Trial
5 TrialsResearching Burns
426 CompletedClinical Trials
Who is running the clinical trial?
Ontario Institute for Regenerative MedicineUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
AFP Innovation FundOTHER
4 Previous Clinical Trials
256 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
590 Previous Clinical Trials
1,468,525 Total Patients Enrolled
5 Trials studying Burns
457 Patients Enrolled for Burns
Marc G Jeschke, MD PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
375 Total Patients Enrolled
3 Trials studying Burns
375 Patients Enrolled for Burns
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:TBSA ≥ 5%.\n
You have been admitted to the hospital within 120 hours of burn.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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