BurnsPhase 1/2NCT02350205
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
A Phase 1/2 study testing Self assembled skin substitute (SASS) in people with Burns, run by CHU de Quebec-Universite Laval at 8 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- Self assembled skin substitute (SASS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 8 sitesCanada
- Study dates
- Dec 2015to 31 Jan 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Canada8 sites, 8 recruiting
- Recruiting
Foothill Medcial Centre
Calgary, Alberta, T2N 2T9
Vincent Gabriel, MD
- Recruiting
Mackenzie Health Science's Centre
Edmonton, Alberta, T6G 2B7
Edward Tredget, MD
- Recruiting
Hôpital Sainte Justine
Montreal, Quebec, H3T 1C5
Patricia Bortoluzzi, MD
- Recruiting
CHU de Québec - Unité des grands brûlés
Québec, Quebec, G1J 1Z4
Chanel Beaudoin-Cloutier, MD
- Recruiting
Hospital for Sick Children (Sickkids)
Toronto, Ontario, M5G 1X8
Joel Fish, MD
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1N1
Anthony Papp, MD, PhD
- Recruiting
BC Children's Hospital Plastic Surgery Clinic
Vancouver, British Columbia, V6H 3V4
Sally Hynes, MD
- Recruiting
Winnipeg Health Science Center
Winnipeg, Manitoba, R3A 1R9
Sarvesh Logsetty, MD
About this study
Official title: SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
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
- Being tested
- Self assembled skin substitute (SASS)
- Keywords
- Burn wounds, Burns, Skin substitute
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self assembled skin substitute (SASS)Biological
All patients in Phase B will receive Self assembled skin substitute (SASS)
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SASS) | Experimental | 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) Receives: Biological: Self assembled skin substitute (SASS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of graft take site A vs site B (Phase A 17 patients)
Clinical assessment; Image analysis
Measured: < 1 month
Percentage of graft take of all SASS (Phase A+B)
Clinical assessment
Measured: < 1 month
Percentage of graft take according to sites (Phase A+B)
Clinical assessment
Measured: < 1 month
Secondary outcomes (6)
Scar evaluation site A vs site B (Phase A 17 patients)
Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;
Measured: 3, 6, 12, 24 and 36 months
Scar evaluation according to sites (Phase A+B)
Cutometer; Mexameter; Dermascan; Images;
Measured: 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
Measured: 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
Measured: 24 to 36 months
Quality of life survey (Phase A+B)
Survey BSHS-B ( brief version of the Burn Specific Health Scale)
Measured: 3, 6, 12, 24 and 36 months
Ratio harvested surface vs covered surface (Phase A+B)
Planimetric analysis; Clinical assessment; Images; Image analysis;
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Moulin, CHU de Quebec-Universite Laval
- Investigators
- Veronique J Moulin, PhD, Principal investigator, CHU de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350205
- Sponsor's protocol ID
- LOEX 014
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2015
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
- ClinicalTrials.gov ID
- NCT02350205
- Acronym / sponsor ID
- LOEX 014
- Conditions
- Burns
- Keywords
- Burn wounds, Burns, Skin substitute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SASS) | Experimental | Biological: Self assembled skin substitute (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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self assembled skin substitute (SASS)All patients in Phase B will receive Self assembled skin substitute (SASS) | Biological | Treatment (SASS) |
Primary outcome
Percentage of graft take site A vs site B (Phase A 17 patients)
Time frame: < 1 month
Clinical assessment; Image analysis
Percentage of graft take of all SASS (Phase A+B)
Time frame: < 1 month
Clinical assessment
Percentage of graft take according to sites (Phase A+B)
Time frame: < 1 month
Clinical assessment
6 secondary outcomes
Scar evaluation site A vs site B (Phase A 17 patients)
Time frame: 3, 6, 12, 24 and 36 months
Scar evaluation according to sites (Phase A+B)
Time frame: 3, 6, 12, 24 and 36 months
Incidence of adverse events site A vs site B (Phase A 17 patients)
Time frame: 24 to 36 months
Incidence of adverse events of all SASS (Phase A+B)
Time frame: 24 to 36 months
Quality of life survey (Phase A+B)
Time frame: 3, 6, 12, 24 and 36 months
Ratio harvested surface vs covered surface (Phase A+B)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronique J Moulin, PhD principal investigator
CHU de Quebec
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Self assembled skin substitute (SASS) in people with Burns, run by CHU de Quebec-Universite Laval at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronique J Moulin, PhD (418-525-4444 ext. 61715, veronique.moulin@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of graft take site A vs site B (Phase A 17 patients) (time frame: < 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.