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.

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 Overview

• Status: Recruiting
• Conditions: Burns
• Intervention / Treatment: Biological: Self assembled skin substitute (SASS)

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Veronique J Moulin, PhD; Phone Number: 61715 418-525-4444; Email: veronique.moulin@fmed.ulaval.ca
• Study Contact Backup: Name: Lucie Germain, PhD; Phone Number: 61696 418-525-4444; Email: lucie.germain@fmed.ulaval.ca

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); All patients in Phase B will receive Self assembled skin substitute (SASS)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Scar evaluation according to sites (Phase A+B)	Cutometer; Mexameter; Dermascan; Images;	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	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	24 to 36 months
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
Ratio harvested surface vs covered surface (Phase A+B)	Planimetric analysis; Clinical assessment; Images; Image analysis;	1 month

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Veronique J Moulin, PhD, CHU de Quebec

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimated): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Burns; Burn wounds; Skin substitute
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: LOEX 014