SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
Recruiting now · Phase 1/Phase 2
Conditions studied: Burns
In brief
This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.
Key facts
- Study ID
- NCT02350205
- Run by
- CHU de Quebec-Universite Laval
- People needed
- 52
- Starts
- 2015-12-01
- Expected to finish
- 2029-01-31
- Last updated by the study team
- 2026-08-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Foothill Medcial Centre — Calgary, Alberta, Canada (enrolling)
- Mackenzie Health Science's Centre — Edmonton, Alberta, Canada (enrolling)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
- BC Children's Hospital Plastic Surgery Clinic — Vancouver, British Columbia, Canada (enrolling)
- Winnipeg Health Science Center — Winnipeg, Manitoba, Canada (enrolling)
- Hospital for Sick Children (Sickkids) — Toronto, Ontario, Canada (enrolling)
- Hôpital Sainte Justine — Montreal, Quebec, Canada (enrolling)
- CHU de Québec - Unité des grands brûlés — Québec, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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