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.
Study Type
OBSERVATIONAL
Enrollment
4
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
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.
Time frame: 2 Years
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.
Time frame: 2 Years
To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.
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).
Time frame: 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.
Time frame: 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.
Time frame: 2 years
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