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

NCT ID: NCT02350205

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2029-01-31

Brief 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.

Conditions

Burns

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (SASS)

Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)

Group Type: EXPERIMENTAL

Self assembled skin substitute (SASS)

Intervention Type: BIOLOGICAL

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

Interventions

Self assembled skin substitute (SASS)

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

Intervention Type: BIOLOGICAL

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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Veronique Moulin

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronique J Moulin, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec

Locations

Foothill Medcial Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

Mackenzie Health Science's Centre

Edmonton, Alberta, Canada

Site Status: RECRUITING

BC Children's Hospital Plastic Surgery Clinic

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Winnipeg Health Science Center

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Hospital for Sick Children (Sickkids)

Toronto, Ontario, Canada

Site Status: RECRUITING

Hôpital Sainte Justine

Montreal, Quebec, Canada

Site Status: RECRUITING

CHU de Québec - Unité des grands brûlés

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Veronique J Moulin, PhD

Role: CONTACT

veronique.moulin@fmed.ulaval.ca

418-525-4444 ext. 61715

Lucie Germain, PhD

Role: CONTACT

lucie.germain@fmed.ulaval.ca

418-525-4444 ext. 61696

Facility Contacts

Vincent Gabriel, MD

Role: primary

Edward Tredget, MD

Role: primary

Sally Hynes, MD

Role: primary

Sarvesh Logsetty, MD

Role: primary

Joel Fish, MD

Role: primary

Patricia Bortoluzzi, MD

Role: primary

Chanel Beaudoin-Cloutier, MD

Role: primary

Other Identifiers

LOEX 014

Identifier Type: -

Identifier Source: org_study_id