About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Self assembled skin substitute (SASS)