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

Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Recruiting
CT.gov ID
NCT02350205
Collaborator
(none)
17
Enrollment
7
Locations
2
Arms
120
Duration (Months)
2.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Self assembled skin substitute (SASS)
  • Procedure: Split-thickness autograft
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (SASS)

All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples).

Biological: Self assembled skin substitute (SASS)
Two site A / B, an area of about 50-100 cm2 are selected. The two sites are side by side and subjected to similar stresses. The type of graft (split thickness autograft or SASS) for the site A or B has been determined in advance.
Active Comparator: Control (split-thickness autograft)

All patients will receive both SASS and Split-thickness autograft (paired samples).

Procedure: Split-thickness autograft
Two site A / B, an area of about 50-100 cm2 are selected. The two sites are side by side and subjected to similar stresses. The type of graft (split thickness autograft or SASS) for the site A or B has been determined in advance.

Outcome Measures

Primary Outcome Measures

  1. Percentage of graft take site A vs site B [< 1 month]

    Clinical assessment; Image analysis

  2. Percentage of graft take of all SASS [< 1 month]

    Clinical assessment

  3. Percentage of graft take according to sites [< 1 month]

    Clinical assessment

Secondary Outcome Measures

  1. Scar evaluation site A vs site B [3, 6, 12, 24 and 36 months]

    Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;

  2. Scar evaluation according to sites [3, 6, 12, 24 and 36 months]

    Cutometer; Mexameter; Dermascan; Images;

  3. Incidence of adverse events site A vs site B [24 to 36 months]

    Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

  4. Incidence of adverse events of all SASS [24 to 36 months]

    Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

  5. Quality of life survey [3, 6, 12, 24 and 36 months]

    Survey BSHS-B ( brief version of the Burn Specific Health Scale)

  6. Ratio harvested surface vs covered surface [1 month]

    Planimetric analysis; Clinical assessment; Images; Image analysis;

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Foothill Medcial Centre Calgary Alberta Canada T2N 2T9
2 Mackenzie Health Science's Centre Edmonton Alberta Canada T6G 2B7
3 BC Children's Hospital Plastic Surgery Clinic Vancouver British Columbia Canada V6H 3V4
4 Winnipeg Health Science Center Winnipeg Manitoba Canada R3A 1R9
5 Hospital for Sick Children (Sickkids) Toronto Ontario Canada M5G 1X8
6 Hôpital Sainte Justine Montréal Quebec Canada H3T 1C5
7 CHU de Québec - Unité des grands brûlés Québec Canada G1J 1Z4

Sponsors and Collaborators

  • CHU de Quebec-Universite Laval

Investigators

  • Principal Investigator: François A Auger, MD, CHU de Quebec

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Francois A. Auger, researcher, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:
NCT02350205
Other Study ID Numbers:
  • LOEX 014
First Posted:
Jan 29, 2015
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Keywords provided by Dr Francois A. Auger, researcher, CHU de Quebec-Universite Laval
Burn wounds
Burns
Skin substitute
Additional relevant MeSH terms:
Burns

Study Results

No Results Posted as of Aug 25, 2022