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Evaluation of Autologous Engineered Skin Substitute (ESS-W) Compared to Meshed, Split-Thickness Autograft (AG) for Treatment of Deep Partial- and Full-Thickness Thermal Burn Wounds in Adult Patients
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds. The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area.
Details
| Lead sponsor | Amarantus BioScience Holdings, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 10 |
| Start date | 2016-09 |
| Completion | 2020-07 |
Conditions
- Thermal Injury
- Deep Partial-Thickness Burn
- Full-Thickness Burn
Interventions
- Autologous Engineered Skin Substitute
- Split-Thickness Autograft (AG)
Primary outcomes
- Incidence and severity of infections at grafting sites — Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day. - Incidence of re-grafting — Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day. - Incidence of adverse events that are related to study treatment and associated with the grafting site — Up to Month 36 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day - Incidence of all adverse events. — Up to Month 36 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day - Percentage engraftment as determined by the Investigator through clinical assessment — Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day - Percentage engraftment as determined by an independent observer through clinical assessment — Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Countries
United States