Clinical trial
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
Name
LOEX 014
Description
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.
Trial arms
Trial start
2015-12-01
Estimated PCD
2028-01-01
Trial end
2029-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Self assembled skin substitute (SASS)
All patients in Phase B will receive Self assembled skin substitute (SASS)
Arms:
Treatment (SASS)
Size
52
Primary endpoint
Percentage of graft take site A vs site B (Phase A 17 patients)
< 1 month
Percentage of graft take of all SASS (Phase A+B)
< 1 month
Percentage of graft take according to sites (Phase A+B)
< 1 month
Eligibility 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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2023-09-15
1 organization
1 product
1 indication
Organization
CHU de Quebec-Universite LavalIndication
Burns