A Phase 1/2 interventional study of Self assembled skin substitute (SASS) in Burns, sponsored by CHU de Quebec-Universite Laval. Recruiting at 8 sites in Canada. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by CHU de Quebec-Universite Laval · Phase 1/2, Interventional, and Treatment
Among 42 studies in Burns with a site in Canada — 14 open to participants now, 15 under way, 1 of them phase 3. Burns · Canada.
Among the 42 studies in Burns with a site in Canada, this one is the 8th largest by planned enrollment of the 36 interventional ones that give a count, is one of 2 that started in 2015, is one of 4 in phase 1/2, reaches primary completion later than 7 of the 14 other live ones, and was the 18th registered.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
Browse Burns studies →14 of the 42 studies in Burns with a site in Canada are open now. Recruiting first, the newest first:
Birch BioMed Inc · Sites in Canada
St. Justine's Hospital · Sites in Canada
University of Manitoba · Sites in Canada
University of Manitoba · Sites in Canada
University of Manitoba · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 9 · Phase 3 4 · Phase 4 3
First in 2005; this study’s year is marked. 2 started in 2015.
This study's planned enrollment of 52 is above the median of 40 across 663 interventional studies indexed under Burns.
Median enrollment 30 across the 36 interventional studies, 40 across the 5 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 42 have an industry lead sponsor. The 10 most frequent:
CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
CHU de Quebec-Universite Laval has 1 study filed under Burns — fewer than ten, so there is no comparison to draw.
2 of the studies in Burns with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06807021Phase 3Birch BioMed IncPost-Operative Use of FS2 to Mitigate Scarring in Burn Patients | 2027-09 |
| NCT07850557Centre hospitalier de l'Université de Montréal (CHUM)Hypertrophic Scar Prosthetic Pressure in Burn Amputee | 2026-12-31 |
Among the 42 studies in Burns with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Biological: Self assembled skin substitute (SASS)
All patients in Phase B will receive Self assembled skin substitute (SASS)
Percentage of graft take site A vs site B (Phase A 17 patients)
Clinical assessment; Image analysis
Time frame: < 1 month
Percentage of graft take of all SASS (Phase A+B)
Clinical assessment
Time frame: < 1 month
Percentage of graft take according to sites (Phase A+B)
Clinical assessment
Time frame: < 1 month
Scar evaluation site A vs site B (Phase A 17 patients)
Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;
Time frame: 3, 6, 12, 24 and 36 months
Scar evaluation according to sites (Phase A+B)
Cutometer; Mexameter; Dermascan; Images;
Time frame: 3, 6, 12, 24 and 36 months
Incidence of adverse events site A vs site B (Phase A 17 patients)
Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other
Time frame: 24 to 36 months
Incidence of adverse events of all SASS (Phase A+B)
Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other
Time frame: 24 to 36 months
Quality of life survey (Phase A+B)
Survey BSHS-B ( brief version of the Burn Specific Health Scale)
Time frame: 3, 6, 12, 24 and 36 months
Ratio harvested surface vs covered surface (Phase A+B)
Planimetric analysis; Clinical assessment; Images; Image analysis;
Time frame: 1 month
Started Dec 2015 (actual). Primary completion is estimated for Jan 2028, 145 months after the start.
How these figures are worked out, and which studies are left out of them.
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CHU de Quebec-Universite Laval →