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| Name | Class |
|---|---|
| Synovis Surgical Innovations | INDUSTRY |
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The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veritas Collagen Matrix | Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hernia recurrence | Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, and 2 years), or when patients present with symptoms, with primary endpoint at 2 years. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Medical and Surgical Complications | Medical and Surgical Complications, including seroma, wound infection or other concurrent infection, hematoma, fistula, ileus, skin necrosis, wound dehiscence, or any other device-related events, will be evaluated through physical exam and/or CT scans at 30 days, 6 months, 1 year, and 2 years, or when patients present with symptoms. These will be reported as total number of each complication within the total number of patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Study surgeons will recruit patients from within their own practice, or through their typical referring sources.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Department of Surgery | Jacksonville | Florida | 32224 | United States | ||
| Watson Clinic Center for Research |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| 2 years |
| Change in Quality of Life | Patients will complete questionnaires regarding physical functioning including activities of daily living, work productivity, and patient comfort at various timepoints after implant at baseline, and at all follow-up visits. Outcomes will be reported in the change from baseline to 2-years. | Baseline to 2 Years |
| Lakeland |
| Florida |
| 33805 |
| United States |
| Atlanta Colon & Rectal Surgery, P.A. | Atlanta | Georgia | 30274 | United States |
| Pratt Medical Center | Fredericksburg | Virginia | 22407 | United States |