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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2028

Interventions

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

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Scar evaluation site A vs site B (Phase A 17 patients)
    • Time Frame: 3, 6, 12, 24 and 36 months
    • Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;
  • Scar evaluation according to sites (Phase A+B)
    • Time Frame: 3, 6, 12, 24 and 36 months
    • Cutometer; Mexameter; Dermascan; Images;
  • Incidence of adverse events site A vs site B (Phase A 17 patients)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 1 month
    • Planimetric analysis; Clinical assessment; Images; Image analysis;

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CHU de Quebec-Universite Laval
  • Provider of Information About this Clinical Study
    • Principal Investigator: Veronique Moulin, Researcher – CHU de Quebec-Universite Laval
  • Overall Official(s)
    • Veronique J Moulin, PhD, Principal Investigator, CHU de Quebec
  • Overall Contact(s)
    • Veronique J Moulin, PhD, 418-525-4444, veronique.moulin@fmed.ulaval.ca

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