Overview

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.

Eligibility

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;