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

Last updated: September 14, 2023
Sponsor: CHU de Quebec-Universite Laval
Overall Status: Active - Recruiting

Phase

1/2

Condition

Hyponatremia

Skin Wounds

Treatment

Self assembled skin substitute (SASS)

Clinical Study ID

NCT02350205
LOEX 014
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofinapt prospective participants or minors.

Exclusion

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

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Self assembled skin substitute (SASS)
Phase: 1/2
Study Start date:
December 01, 2015
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • Foothill Medcial Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • Mackenzie Health Science's Centre

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • BC Children's Hospital Plastic Surgery Clinic

    Vancouver, British Columbia V6H 3V4
    Canada

    Active - Recruiting

  • Winnipeg Health Science Center

    Winnipeg, Manitoba R3A 1R9
    Canada

    Active - Recruiting

  • Hospital for Sick Children (Sickkids)

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Hôpital Sainte Justine

    Montréal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • CHU de Québec - Unité des grands brûlés

    Québec, G1J 1Z4
    Canada

    Active - Recruiting

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