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

Study Overview
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Brief Summary
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Biological: Self assembled skin substitute (SASS)


Participation Criteria
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Eligibility Criteria
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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;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (SASS)<br>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) | Biological: Self assembled skin substitute (SASS)<br>* All patients in Phase B will receive Self assembled skin substitute (SASS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of graft take site A vs site B (Phase A 17 patients) | Clinical assessment; Image analysis | < 1 month | 
| Percentage of graft take of all SASS (Phase A+B) | Clinical assessment | < 1 month | 
| Percentage of graft take according to sites (Phase A+B) | Clinical assessment | < 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar evaluation site A vs site B (Phase A 17 patients) | Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images; | 3, 6, 12, 24 and 36 months | 
| Scar evaluation according to sites (Phase A+B) | Cutometer; Mexameter; Dermascan; Images; | 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 | 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 | 24 to 36 months | 
| Quality of life survey (Phase A+B) | Survey BSHS-B ( brief version of the Burn Specific Health Scale) | 3, 6, 12, 24 and 36 months | 
| Ratio harvested surface vs covered surface (Phase A+B) | Planimetric analysis; Clinical assessment; Images; Image analysis; | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn wounds, Burns, Skin substitute