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RecruitingNCT02350205Updated Aug 5, 2026

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

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

From the registry’s dates

  • Started Dec 2015; still recruiting 10 years 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Burns

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Keywords

  • Burn wounds
  • Burns
  • Skin substitute
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 52 is above the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.

Browse CHU de Quebec-Universite Laval studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

Exclusion Criteria:

  • Skin grafting needed only on the face, hands, feet, ears or genital area;
  • Connective tissue diseases;
  • 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;
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (estimated)

Study 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)

    Biological: Self assembled skin substitute (SASS)

Interventions

  • BiologicalSelf assembled skin substitute (SASS)

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

06

What researchers measure

Primary outcomes

  1. Percentage of graft take site A vs site B (Phase A 17 patients)

    Clinical assessment; Image analysis

    Time frame: < 1 month

  2. Percentage of graft take of all SASS (Phase A+B)

    Clinical assessment

    Time frame: < 1 month

  3. Percentage of graft take according to sites (Phase A+B)

    Clinical assessment

    Time frame: < 1 month

Secondary outcomes

  1. 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

  2. Scar evaluation according to sites (Phase A+B)

    Cutometer; Mexameter; Dermascan; Images;

    Time frame: 3, 6, 12, 24 and 36 months

  3. 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

  4. 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

  5. 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

  6. Ratio harvested surface vs covered surface (Phase A+B)

    Planimetric analysis; Clinical assessment; Images; Image analysis;

    Time frame: 1 month

07

Study locations

8 of 8 sites recruiting
  • Foothill Medcial Centre
    Calgary, Alberta T2N 2T9, Canada
    Recruiting
    • Vincent Gabriel, MD · Contact
  • Mackenzie Health Science's Centre
    Edmonton, Alberta T6G 2B7, Canada
    Recruiting
    • Edward Tredget, MD · Contact
  • Vancouver General Hospital
    Vancouver, British Columbia V5Z 1N1, Canada
    Recruiting
    • Anthony Papp, MD, PhD · Contact
  • BC Children's Hospital Plastic Surgery Clinic
    Vancouver, British Columbia V6H 3V4, Canada
    Recruiting
    • Sally Hynes, MD · Contact
  • Winnipeg Health Science Center
    Winnipeg, Manitoba R3A 1R9, Canada
    Recruiting
    • Sarvesh Logsetty, MD · Contact
  • Hospital for Sick Children (Sickkids)
    Toronto, Ontario M5G 1X8, Canada
    Recruiting
    • Joel Fish, MD · Contact
  • Hôpital Sainte Justine
    Montreal, Quebec H3T 1C5, Canada
    Recruiting
    • Patricia Bortoluzzi, MD · Contact
  • CHU de Québec - Unité des grands brûlés
    Québec, Quebec G1J 1Z4, Canada
    Recruiting
    • Chanel Beaudoin-Cloutier, MD · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02350205
Lead sponsor
CHU de Quebec-Universite Laval
Responsible party
Veronique Moulin (Researcher, CHU de Quebec-Universite Laval) — Principal investigator
First posted
Jan 29, 2015
Start date
Dec 2015
Primary completion
Jan 2028 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Aug 5, 2026

Study contacts

Veronique J Moulin, PhD
Contact
veronique.moulin@fmed.ulaval.ca
418-525-4444 ext. 61715
Lucie Germain, PhD
Contact
lucie.germain@fmed.ulaval.ca
418-525-4444 ext. 61696
Veronique J Moulin, PhD
principal investigator · CHU de Quebec

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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