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

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ClinicalTrials.gov Identifier: NCT02350205
Recruitment Status : Recruiting
First Posted : January 29, 2015
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Francois A. Auger, CHU de Quebec-Universite Laval

Study Description
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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
Burns Biological: Self assembled skin substitute (SASS) Procedure: Split-thickness autograft Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2015
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percentage of graft take site A vs site B [ Time Frame: < 1 month ]
    Clinical assessment; Image analysis

  2. Percentage of graft take of all SASS [ Time Frame: < 1 month ]
    Clinical assessment

  3. Percentage of graft take according to sites [ Time Frame: < 1 month ]
    Clinical assessment


Secondary Outcome Measures :
  1. Scar evaluation site A vs site B [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;

  2. Scar evaluation according to sites [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Cutometer; Mexameter; Dermascan; Images;

  3. Incidence of adverse events site A vs site B [ Time Frame: 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 [ Time Frame: 24 to 36 months ]
    Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

  5. Quality of life [ Time Frame: 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 [ Time Frame: 1 month ]
    Planimetric analysis; Clinical assessment; Images; Image analysis;


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350205


Contacts
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Contact: Lucie Germain, PhD 418 6490252 ext 1696 lucie.germain@fmed.ulaval.ca
Contact: François A Auger, MD 418 6490252 ext 1662 francois.auger@fmed.ulaval.ca

Locations
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Canada, Quebec
CHUM - Hôtel Dieu Recruiting
Montréal, Quebec, Canada, H2W 1T8
Contact: Louise Duranceau, MD    514-890-8000 ext 14444      
Canada
CHU de Québec - Unité des grands brûlés Recruiting
Québec, Canada, G1J 1Z4
Contact: Amélie Dumas, MD    418-649-0252 ext 5990      
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: François A Auger, MD CHU de Quebec
More Information
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Responsible Party: Dr Francois A. Auger, researcher, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02350205    
Other Study ID Numbers: LOEX 014
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Keywords provided by Dr Francois A. Auger, CHU de Quebec-Universite Laval:
Burn wounds
Burns
Skin substitute
Additional relevant MeSH terms:
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Burns
Wounds and Injuries