← Back to Search

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

Must not have

Skin grafting needed only on the face, hands, feet, ears or genital area

Connective tissue diseases

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need skin grafting on my face, hands, feet, ears, or genital area only.

Select...

I have a connective tissue disease.

Select...

I had a blood clotting disorder before I was burned.

Select...

I had uncontrolled diabetes before getting a burn injury.

Select...

My wounds are covered until the grafts are prepared.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met