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Tissue Engineering

Skin Substitute for Burns

Phase 1 & 2
Recruiting
Led By Veronique J Moulin, PhD
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Deep second degree burns or third degree burns over 50% TBSA at time of recruitment or as determined by the surgeon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 24 and 36 months
Awards & highlights

Study Summary

This trial will test how safe and effective a new skin substitute is for treating full-thickness burns.

Who is the study for?
This trial is for individuals with deep second-degree or third-degree burns covering over 50% of their body, where traditional skin graft donor sites are limited. It's not suitable for those needing grafts only on sensitive areas like the face or hands, people with uncontrolled diabetes, coagulation disorders, connective tissue diseases, immunodeficiency before being burned, or hypersensitivity to bovine proteins.Check my eligibility
What is being tested?
The trial is testing a Self Assembled Skin Substitute (SASS) as a permanent solution for severe burn wounds when there's not enough healthy skin available for grafts. The goal is to see if SASS can safely and effectively replace damaged skin.See study design
What are the potential side effects?
Potential side effects may include reactions at the wound site due to sensitivity to materials in SASS such as bovine proteins which could cause redness, swelling or infection; however specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe burns covering more than half of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 24 and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 24 and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of graft take according to sites (Phase A+B)
Percentage of graft take of all SASS (Phase A+B)
Percentage of graft take site A vs site B (Phase A 17 patients)
Secondary outcome measures
Incidence of adverse events of all SASS (Phase A+B)
Incidence of adverse events site A vs site B (Phase A 17 patients)
Quality of life survey (Phase A+B)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SASS)Experimental Treatment1 Intervention
Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
168 Previous Clinical Trials
107,136 Total Patients Enrolled
Veronique J Moulin, PhDPrincipal InvestigatorCHU de Quebec
François A Auger, MDPrincipal InvestigatorCHU de Quebec

Media Library

Self Assembled Skin Substitute (SASS) (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT02350205 — Phase 1 & 2
Burns Research Study Groups: Treatment (SASS)
Burns Clinical Trial 2023: Self Assembled Skin Substitute (SASS) Highlights & Side Effects. Trial Name: NCT02350205 — Phase 1 & 2
Self Assembled Skin Substitute (SASS) (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02350205 — Phase 1 & 2
~15 spots leftby Jan 2028
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