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.
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.
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;
Single group
Self assembled skin substitute (SASS)
Biological/VaccineAll patients in Phase B will receive Self assembled skin substitute (SASS)
Percentage of graft take site A vs site B (Phase A 17 patients)
Clinical assessment; Image analysis
Percentage of graft take of all SASS (Phase A+B)
Clinical assessment
Percentage of graft take according to sites (Phase A+B)
Clinical assessment
Scar evaluation site A vs site B (Phase A 17 patients)
Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;
Scar evaluation according to sites (Phase A+B)
Cutometer; Mexameter; Dermascan; Images;
Incidence of adverse events site A vs site B (Phase A 17 patients)
Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other
Incidence of adverse events of all SASS (Phase A+B)
Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other
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