SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
CHU de Quebec-Universite Laval
52 participants
Dec 1, 2015
INTERVENTIONAL
Conditions
Summary
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 Criteria3
- 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 Criteria7
- 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;
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Interventions
All patients in Phase B will receive Self assembled skin substitute (SASS)
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT02350205