Self Assembled Skin Substitute for treating severe burn wounds

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

This study tests if a new skin substitute can help heal severe burn wounds for people who don’t have enough healthy skin to use for traditional grafts.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sex: All
• Sponsor: CHU de Quebec-Universite Laval (Academic / other)
• Locations: 7 sites (Calgary, Alberta and 6 other locations)
• Trial ID: NCT02350205 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Self Assembled Skin Substitute (SASS) grafts as a permanent solution for full-thickness burn wounds that require coverage, particularly when donor sites for traditional skin grafts are limited. The study involves patients with deep second or third-degree burns covering a significant portion of their body. Participants will receive SASS grafts to assess their potential as a viable alternative to conventional treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with deep second or third-degree burns affecting over 50% of their total body surface area and limited donor site availability.

Not a fit: Patients needing skin grafts only on the face, hands, feet, ears, or genital area may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new permanent treatment option for patients with severe burn injuries.

How similar studies have performed: Other studies have explored skin substitutes, but the specific use of SASS grafts for severe burns is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;
* Limited availability of donor sites for autografts;
* Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.

Exclusion Criteria:

* Skin grafting needed only on the face, hands, feet, ears or genital area;
* Connective tissue diseases;
* Hypersensitivity to bovine proteins;
* Coagulation disorders prior being burned;
* Immunodeficiency prior being burned;
* Uncontrolled diabetes prior being burned;
* Permanent wound coverage before SASS grafts are ready;

Where this trial is running

Calgary, Alberta and 6 other locations

• Foothill Medcial Centre — Calgary, Alberta, Canada (Recruiting)
• Mackenzie Health Science's Centre — Edmonton, Alberta, Canada (Recruiting)
• BC Children's Hospital Plastic Surgery Clinic — Vancouver, British Columbia, Canada (Recruiting)
• Winnipeg Health Science Center — Winnipeg, Manitoba, Canada (Recruiting)
• Hospital for Sick Children (Sickkids) — Toronto, Ontario, Canada (Recruiting)
• Hôpital Sainte Justine — Montreal, Quebec, Canada (Recruiting)
• CHU de Québec - Unité des grands brûlés — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Veronique J Moulin, PhD — CHU de Quebec
• Study coordinator: Veronique J Moulin, PhD

Conditions Burns; Burn wounds; Skin substitute