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

Burns

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.

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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 Centre
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Vincent Gabriel, MD

Hospital for Sick Children (Sickkids)
Hospital for Sick Children (Sickkids)
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Joel Fish, MD

Winnipeg Health Science Center
Winnipeg Health Science Center
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Sarvesh Logsetty, MD

Mackenzie Health Science's Centre
Mackenzie Health Science's Centre
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Edward Tredget, MD

Hôpital Sainte Justine
Hôpital Sainte Justine
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Patricia Bortoluzzi, MD

BC Children's Hospital Plastic Surgery Clinic
BC Children's Hospital Plastic Surgery Clinic
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Sally Hynes, MD

Study Sponsored By
CHU de Quebec-Universite Laval
Participants Required
More Information
Study ID: NCT02350205