Integra®-SC for Burns

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sunnybrook Health Sciences Centre, Toronto, Canada
Burns
Integra®-SC - Device
Eligibility
18+
All Sexes
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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

1 of 3

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

1 of 3

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: Device
Control
Device
ActiveComparator Group · 1 Intervention: Integra® · Intervention Types: Device

Trial 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
Photo of sunnybrook health sciences centre 1Photo of sunnybrook health sciences centre 2Photo of sunnybrook health sciences centre 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.