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| Name | Class |
|---|---|
| SygNola, LLC | INDUSTRY |
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This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Open Wounds
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeoThelium FT + SOC | Experimental | Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoThelium FT | Other | NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Wound Closure | The primary endpoint will be the percentage of target ulcers that achieve complete wound closure. | 1-14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Wound Area Change | The percentage change in wound area from TV-1 to TV-13 will be measured weekly using standardized method of wound area measurement and physical examination. | 1-12 weeks |
| Follow-Up Closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelina Ferguson, DNP | SygNola, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedCentris of Hammond | Hammond | Louisiana | 70403 | United States |
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NeoThelium FT in addition to Standard of Care
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Number of wounds remaining closed during the 2-week follow-up
| 2 weeks |
| Time to Closure | Average number of grafts/weeks used to achieve wound closure | 1-12 weeks |