Clinical trial Recruiting at 8 sites Phase1; Phase2 Interventional

Self Assembled Skin Substitute for treating severe burn wounds

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

Run by CHU de Quebec-Universite Laval · NCT02350205 · Data updated 2026-11-12

This study tests if a new skin substitute can help heal severe burn wounds for people who don’t have enough healthy skin to use for traditional grafts.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
SexAll
Enrollment52 (estimated)
SponsorCHU de Quebec-Universite Laval
Academic / other
Locations8 sites (Calgary, Alberta and 7 other locations)
StatusRecruiting
StartedDecember 2015
Main results expectedJanuary 2028
Study endsJanuary 31, 2029
Registry record updatedAugust 5, 2026
Trial IDNCT02350205 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with deep second or third-degree burns affecting over 50% of their total body surface area and limited donor site availability.

Probably not a fit

Patients needing skin grafts only on the face, hands, feet, ears, or genital area may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of Self Assembled Skin Substitute (SASS) grafts as a permanent solution for full-thickness burn wounds that require coverage, particularly when donor sites for traditional skin grafts are limited. The study involves patients with deep second or third-degree burns covering a significant portion of their body. Participants will receive SASS grafts to assess their potential as a viable alternative to conventional treatments.

Why it matters

Potential benefit: If successful, this approach could provide a new permanent treatment option for patients with severe burn injuries.

How similar studies have gone: Other studies have explored skin substitutes, but the specific use of SASS grafts for severe burns is a novel approach.

Who can join: the full rules

Show full inclusion / exclusion 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;

Where it's running

  • Foothill Medcial Centre
    Calgary, Alberta, Canada
    Recruiting
  • Mackenzie Health Science's Centre
    Edmonton, Alberta, Canada
    Recruiting
  • Vancouver General Hospital
    Vancouver, British Columbia, Canada
    Recruiting
  • BC Children's Hospital Plastic Surgery Clinic
    Vancouver, British Columbia, Canada
    Recruiting
  • Winnipeg Health Science Center
    Winnipeg, Manitoba, Canada
    Recruiting
  • Hospital for Sick Children (Sickkids)
    Toronto, Ontario, Canada
    Recruiting
Show 2 more locations
  • Hôpital Sainte Justine
    Montreal, Quebec, Canada
    Recruiting
  • CHU de Québec - Unité des grands brûlés
    Québec, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.