SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

NCT02350205 · tracked via the Priya Life Science Canada tracker

Sponsor

CHU de Quebec-Universite Laval

Phase

Phase 1/2

Started

2015-12

Last updated

2026-08-05

Condition(s) studied

Burns

Investigational drug(s) / intervention(s)

Self assembled skin substitute (SASS) →

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

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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;

Primary outcome measure(s)

Percentage of graft take site A vs site B (Phase A 17 patients) — < 1 month
Clinical assessment; Image analysis
Percentage of graft take of all SASS (Phase A+B) — < 1 month
Clinical assessment
Percentage of graft take according to sites (Phase A+B) — < 1 month
Clinical assessment

Trial sites (8)

Facility	City	Region	Status
Foothill Medcial Centre	Calgary	Alberta	Recruiting
Mackenzie Health Science's Centre	Edmonton	Alberta	Recruiting
Vancouver General Hospital	Vancouver	British Columbia	Recruiting
BC Children's Hospital Plastic Surgery Clinic	Vancouver	British Columbia	Recruiting
Winnipeg Health Science Center	Winnipeg	Manitoba	Recruiting
Hospital for Sick Children (Sickkids)	Toronto	Ontario	Recruiting
Hôpital Sainte Justine	Montreal	Quebec	Recruiting
CHU de Québec - Unité des grands brûlés	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02350205 on ClinicalTrials.gov ↗ ← All trials in Canada