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NCT Number: NCT02350205

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

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.

Recruiting

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Key information

Conditions

Burns Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Foothill Medcial Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Self assembled skin substitute (SASS)

Biological

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

Primary outcomes

  1. Percentage of graft take site A vs site B (Phase A 17 patients)

    Time frame: < 1 month

    Clinical assessment; Image analysis

  2. Percentage of graft take of all SASS (Phase A+B)

    Time frame: < 1 month

    Clinical assessment

  3. Percentage of graft take according to sites (Phase A+B)

    Time frame: < 1 month

    Clinical assessment

Secondary outcomes

  1. 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;

  2. Scar evaluation according to sites (Phase A+B)

    Time frame: 3, 6, 12, 24 and 36 months

    Cutometer; Mexameter; Dermascan; Images;

  3. 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

  4. 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

  5. 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)

  6. Ratio harvested surface vs covered surface (Phase A+B)

    Time frame: 1 month

    Planimetric analysis; Clinical assessment; Images; Image analysis;

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Germain, PhD

CONTACT

[email protected]

418-525-4444 ext. 61696

Veronique J Moulin, PhD

CONTACT

[email protected]

418-525-4444 ext. 61715

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2028
Study completion
2029
First posted
Jan 29, 2015
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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