SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
BurnsThis 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
0 and up
Participation 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;
Study Location
Foothill Medcial Centre
Foothill Medcial CentreCalgary, Alberta
Canada
Contact Study Team
Vincent Gabriel, MD
Hospital for Sick Children (Sickkids)
Hospital for Sick Children (Sickkids)Toronto, Ontario
Canada
Contact Study Team
Joel Fish, MD
Winnipeg Health Science Center
Winnipeg Health Science CenterWinnipeg, Manitoba
Canada
Contact Study Team
Sarvesh Logsetty, MD
Mackenzie Health Science's Centre
Mackenzie Health Science's CentreEdmonton, Alberta
Canada
Contact Study Team
Edward Tredget, MD
Hôpital Sainte Justine
Hôpital Sainte JustineMontréal, Quebec
Canada
Contact Study Team
Patricia Bortoluzzi, MD
BC Children's Hospital Plastic Surgery Clinic
BC Children's Hospital Plastic Surgery ClinicVancouver, British Columbia
Canada
Contact Study Team
Sally Hynes, MD
- Study Sponsored By
- CHU de Quebec-Universite Laval
- Participants Required
- More Information
- Study ID:
NCT02350205