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

Phase 2RecruitingNCT02350205

CHU de Quebec-Universite Laval52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns

Interventions

Self assembled skin substitute (SASS)BIOLOGICAL

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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;

Locations (7)

Foothill Medcial Centre

Calgary, Alberta, Canada

RECRUITING

Mackenzie Health Science's Centre

Edmonton, Alberta, Canada

RECRUITING

BC Children's Hospital Plastic Surgery Clinic

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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

Clinical assessment; Image analysis

Time frame: < 1 month

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

Clinical assessment

Time frame: < 1 month

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

Clinical assessment

Time frame: < 1 month

Secondary Outcomes

Scar evaluation site A vs site B (Phase A 17 patients)

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

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

Scar evaluation according to sites (Phase A+B)

Cutometer; Mexameter; Dermascan; Images;

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

Incidence of adverse events site A vs site B (Phase A 17 patients)

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

Time frame: 24 to 36 months

Incidence of adverse events of all SASS (Phase A+B)

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

Time frame: 24 to 36 months

Quality of life survey (Phase A+B)

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

Central Contacts

Veronique J Moulin, PhD

CONTACT

418-525-4444 veronique.moulin@fmed.ulaval.ca

Lucie Germain, PhD

CONTACT

418-525-4444 lucie.germain@fmed.ulaval.ca

Data from ClinicalTrials.gov

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