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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 8 sites (Calgary, Alberta and 7 other locations) |
| Status | Recruiting |
| Started | December 2015 |
| Main results expected | January 2028 |
| Study ends | January 31, 2029 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT02350205 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
- Principal investigator: Veronique J Moulin, PhD — CHU de Quebec
- Study coordinator: Veronique J Moulin, PhD
- Email: veronique.moulin@fmed.ulaval.ca
- Phone: 418-525-4444
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Early detection of sepsis-related blood clotting problems in severe burn patients
This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.
-
THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers
This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.
-
Efferon LPS hemoadsorption for severe burns
This study tests whether adding Efferon LPS hemoadsorption to standard care can help burn patients with high illness scores see if their symptoms improve and prevent organ failure.
-
Wearable hip-robot training to improve walking after major lower-leg burns
This 12-week program will try using a wearable hip-assist robot during daily physiotherapy to help adults who still have walking problems six months after large lower-extremity burns walk better.
-
Tilapia skin versus regular dressings for second- and third-degree burns
This trial will test whether tilapia fish skin dressings help people with second- or third-degree burns heal better than regular dressings.
-
Presepsin blood test for early sepsis detection in severe burn patients
This project will test whether a blood marker called presepsin can detect sepsis early in adults who have severe burns covering at least 20% of their body.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.