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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02350205
• Other study ID #: LOEX 014
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: January 2029

Study information

• Verified date: September 2023
• Source: CHU de Quebec-Universite Laval
• Contact: Veronique J Moulin, PhD
• Phone: 418-525-4444
• Email: veronique.moulin[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 2029
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
Canada	Foothill Medcial Centre	Calgary	Alberta
Canada	Mackenzie Health Science's Centre	Edmonton	Alberta
Canada	Hôpital Sainte Justine	Montréal	Quebec
Canada	CHU de Québec - Unité des grands brûlés	Québec
Canada	Hospital for Sick Children (Sickkids)	Toronto	Ontario
Canada	BC Children's Hospital Plastic Surgery Clinic	Vancouver	British Columbia
Canada	Winnipeg Health Science Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of graft take site A vs site B (Phase A 17 patients)	Clinical assessment; Image analysis	< 1 month
Primary	Percentage of graft take of all SASS (Phase A+B)	Clinical assessment	< 1 month
Primary	Percentage of graft take according to sites (Phase A+B)	Clinical assessment	< 1 month
Secondary	Scar evaluation site A vs site B (Phase A 17 patients)	Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;	3, 6, 12, 24 and 36 months
Secondary	Scar evaluation according to sites (Phase A+B)	Cutometer; Mexameter; Dermascan; Images;	3, 6, 12, 24 and 36 months
Secondary	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	24 to 36 months
Secondary	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	24 to 36 months
Secondary	Quality of life survey (Phase A+B)	Survey BSHS-B ( brief version of the Burn Specific Health Scale)	3, 6, 12, 24 and 36 months
Secondary	Ratio harvested surface vs covered surface (Phase A+B)	Planimetric analysis; Clinical assessment; Images; Image analysis;	1 month