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Sponsor decision, not safety related.
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This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XenMatrix |
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| Measure | Description | Time Frame |
|---|---|---|
| To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery. | Any hernia which is identified or confirmed by the investigator in approximately the same position as the hernia repair during any follow up visit after a XenMatrix™ surgical graft has been placed will be considered a recurrent hernia. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation. | Procedural and device related AEs collected from surgery until 24 months post surgery. | 2 Years |
| To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are diagnosed with a ventral or incisional hernia that require a component separation repair with the use of a biological graft.
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| Name | Affiliation | Role |
|---|---|---|
| Karl LeBlanc, MD | Our Lady of the Lake Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Procedure time will be defined as beginning when the investigator makes the initial skin incision and ending when the skin closure is completed (skin to skin). |
| Day 0 |
| To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation. | Changes in QOL will be assessed from baseline to 24 months utilizing the Short Form-36 (SF-36) version 2. | 2 years |
| To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft. | Subjects who have their grafts placed in different tissue planes will have their recurrence rate, complication type and frequency examined to determine if there are any gross differences. | 2 years |