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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02350205
Other study ID # LOEX 014
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2015
Est. completion date January 2029

Study information

Verified date September 2023
Source CHU de Quebec-Universite Laval
Contact Veronique J Moulin, PhD
Phone 418-525-4444
Email veronique.moulin@fmed.ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date January 2029
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Self assembled skin substitute (SASS)
All patients in Phase B will receive Self assembled skin substitute (SASS)

Locations

Country Name City State
Canada Foothill Medcial Centre Calgary Alberta
Canada Mackenzie Health Science's Centre Edmonton Alberta
Canada Hôpital Sainte Justine Montréal Quebec
Canada CHU de Québec - Unité des grands brûlés Québec
Canada Hospital for Sick Children (Sickkids) Toronto Ontario
Canada BC Children's Hospital Plastic Surgery Clinic Vancouver British Columbia
Canada Winnipeg Health Science Center Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of graft take site A vs site B (Phase A 17 patients) Clinical assessment; Image analysis < 1 month
Primary Percentage of graft take of all SASS (Phase A+B) Clinical assessment < 1 month
Primary Percentage of graft take according to sites (Phase A+B) Clinical assessment < 1 month
Secondary Scar evaluation site A vs site B (Phase A 17 patients) Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images; 3, 6, 12, 24 and 36 months
Secondary Scar evaluation according to sites (Phase A+B) Cutometer; Mexameter; Dermascan; Images; 3, 6, 12, 24 and 36 months
Secondary 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 24 to 36 months
Secondary 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 24 to 36 months
Secondary Quality of life survey (Phase A+B) Survey BSHS-B ( brief version of the Burn Specific Health Scale) 3, 6, 12, 24 and 36 months
Secondary Ratio harvested surface vs covered surface (Phase A+B) Planimetric analysis; Clinical assessment; Images; Image analysis; 1 month
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