Actively Recruiting

Phase 1
Phase 2
All Genders
NCT02350205

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

Led by CHU de Quebec-Universite Laval · Updated on 2025-07-25

52

Participants Needed

7

Research Sites

682 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Foothill Medcial Centre

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

2

Mackenzie Health Science's Centre

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

3

BC Children's Hospital Plastic Surgery Clinic

Vancouver, British Columbia, Canada, V6H 3V4

Actively Recruiting

4

Winnipeg Health Science Center

Winnipeg, Manitoba, Canada, R3A 1R9

Actively Recruiting

5

Hospital for Sick Children (Sickkids)

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

6

Hôpital Sainte Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

7

CHU de Québec - Unité des grands brûlés

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

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Research Team

V

Veronique J Moulin, PhD

CONTACT

L

Lucie Germain, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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