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

Phase 1

Recruiting

• Conditions: Burns
• Interventions: Biological: Self assembled skin substitute (SASS)

• Registration Number: NCT02350205
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-29
• Study Start: 2015-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2028-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SASS)	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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
Ratio harvested surface vs covered surface (Phase A+B)	1 month	Planimetric analysis; Clinical assessment; Images; Image analysis;

Trial Locations

Locations (7)

Mackenzie Health Science's Centre; 🇨🇦 Edmonton, Alberta, Canada

Foothill Medcial Centre; 🇨🇦 Calgary, Alberta, Canada

BC Children's Hospital Plastic Surgery Clinic; 🇨🇦 Vancouver, British Columbia, Canada

Winnipeg Health Science Center; 🇨🇦 Winnipeg, Manitoba, Canada

Hospital for Sick Children (Sickkids); 🇨🇦 Toronto, Ontario, Canada

Hôpital Sainte Justine; 🇨🇦 Montréal, Quebec, Canada

CHU de Québec - Unité des grands brûlés; 🇨🇦 Québec, Canada