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

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02350205

Enrollment

Registered

2015-01-29

Start date

2015-12-01

Completion date

2029-01-31

Last updated

2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Burn wounds, Burns, Skin substitute

Brief 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.

Interventions

BIOLOGICALSelf assembled skin substitute (SASS)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Percentage of graft take site A vs site B (Phase A 17 patients)	< 1 month	Clinical assessment; Image analysis
Percentage of graft take of all SASS (Phase A+B)	< 1 month	Clinical assessment
Percentage of graft take according to sites (Phase A+B)	< 1 month	Clinical assessment

Secondary

Measure	Time frame	Description
Scar evaluation site A vs site B (Phase A 17 patients)	3, 6, 12, 24 and 36 months	Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;
Scar evaluation according to sites (Phase A+B)	3, 6, 12, 24 and 36 months	Cutometer; Mexameter; Dermascan; Images;
Incidence of adverse events site A vs site B (Phase A 17 patients)	24 to 36 months	Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other
Incidence of adverse events of all SASS (Phase A+B)	24 to 36 months	Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other
Quality of life survey (Phase A+B)	3, 6, 12, 24 and 36 months	Survey BSHS-B ( brief version of the Burn Specific Health Scale)
Ratio harvested surface vs covered surface (Phase A+B)	1 month	Planimetric analysis; Clinical assessment; Images; Image analysis;

Countries

Canada

Contacts

CONTACTVeronique J Moulin, PhD

veronique.moulin@fmed.ulaval.ca418-525-4444

CONTACTLucie Germain, PhD

lucie.germain@fmed.ulaval.ca418-525-4444

PRINCIPAL_INVESTIGATORVeronique J Moulin, PhD

CHU de Quebec

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026