Last updated: September 14, 2023
Sponsor: CHU de Quebec-Universite Laval
Overall Status: Active - Recruiting
Phase
1/2
Condition
Hyponatremia
Skin Wounds
Treatment
Self assembled skin substitute (SASS)
Clinical Study ID
NCT02350205
LOEX 014
All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofinapt prospective participants or minors.
Exclusion
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;
Study Design
Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Self assembled skin substitute (SASS)
Phase: 1/2
Study Start date:
December 01, 2015
Estimated Completion Date:
January 31, 2029
Connect with a study center
Foothill Medcial Centre
Calgary, Alberta T2N 2T9
CanadaActive - Recruiting
Mackenzie Health Science's Centre
Edmonton, Alberta T6G 2B7
CanadaActive - Recruiting
BC Children's Hospital Plastic Surgery Clinic
Vancouver, British Columbia V6H 3V4
CanadaActive - Recruiting
Winnipeg Health Science Center
Winnipeg, Manitoba R3A 1R9
CanadaActive - Recruiting
Hospital for Sick Children (Sickkids)
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Hôpital Sainte Justine
Montréal, Quebec H3T 1C5
CanadaActive - Recruiting
CHU de Québec - Unité des grands brûlés
Québec, G1J 1Z4
CanadaActive - Recruiting
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