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

Laval University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Burns

Treatments: Biological: Self assembled skin substitute (SASS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02350205

LOEX 014

Details and patient eligibility

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.

Enrollment: 52 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Treatment (SASS)

Experimental group

Description:

Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)

Treatment:

Biological: Self assembled skin substitute (SASS)