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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 24 and 36 months

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)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

107,105 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what number of healthcare facilities is this experiment currently being carried out?

"This medical trial is actively recruiting from 10 different sites, three of which are Winnipeg Health Science Center in Manitoba, Foothill Medical Centre in Alberta, and Mackenzie Health Sciences' Centre in Quebec."

Answered by AI

Are enrollees still being accepted in this clinical trial?

"Affirmative. Information on clinicaltrials.gov demonstrates that this investigation is currently seeking volunteers, which was first advertised on January 1st 2015 and most recently updated August 24th 2022. 17 participants are to be sourced from a total of 7 sites for inclusion in the study."

Answered by AI

What is the magnitude of participants in this clinical trial?

"17 suitable participants who meet the prerequisites can join this clinical trial. Known sites include Winnipeg Health Science Centre in Winnipeg, Manitoba and Foothill Medcial Centre in Calgary, Alberta."

Answered by AI

Could you elucidate the primary goals of this research endeavor?

"The primary aim of this medical trial, taking place over a short time period, is to compare the success rate of grafts between two sites. Secondary objectives include assessing patients' quality-of-life using the Brief Burn Specific Health Scale and monitoring adverse events at both locations with clinical assessments. Additionally, scar evaluations are conducted through Cutometer; Mexameter; Dermascan; and imaging technology."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

Veronique Moulin 2015. "SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02350205.

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