Recruiting
Phase 1
Phase 2

Self Assembled Skin Substitute

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT02350205

Conditions

Burns

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Self assembled skin substitute (SASS)

Study Details

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 ID

NCT02350205

Start date

Dec, 2015

Status verified date

Aug, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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)

Interventions

Self assembled skin substitute (SASS)

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

Primary outcome measure

  • Percentage of graft take site A vs site B (Phase A 17 patients) [ Time Frame: < 1 month ]
  • Percentage of graft take of all SASS (Phase A+B) [ Time Frame: < 1 month ]
  • Percentage of graft take according to sites (Phase A+B) [ Time Frame: < 1 month ]

Central Contacts and Locations

Central contacts

Veronique J Moulin, PhD

418-525-4444veronique.moulin@fmed.ulaval.ca

Lucie Germain, PhD

418-525-4444lucie.germain@fmed.ulaval.ca

Locations

Foothill Medcial Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Mackenzie Health Science's Centre

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1N1

BC Children's Hospital Plastic Surgery Clinic

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Winnipeg Health Science Center

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Hospital for Sick Children (Sickkids)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Hôpital Sainte Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

CHU de Québec - Unité des grands brûlés

Recruiting

Québec, Quebec, Canada, G1J 1Z4

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Burn wounds
  • Burns
  • Skin substitute

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-08-05.