A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation|
- 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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]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.
- To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]Procedural and device related AEs collected from surgery until 24 months post surgery.
- To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]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).
- To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Changes in QOL will be assessed from baseline to 24 months utilizing the Short Form-36 (SF-36) version 2.
- To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft. [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305486
|United States, Louisiana|
|Our Lady of the Lake Regional Medical Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Karl LeBlanc, MD||Our Lady of the Lake Regional Medical Center|