A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation (XenMatrix)
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|ClinicalTrials.gov Identifier: NCT01305486|
Recruitment Status : Terminated (Sponsor decision, not safety related.)
First Posted : February 28, 2011
Last Update Posted : January 15, 2013
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||4 participants|
|Official Title:||A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation|
|Study Start Date :||September 2010|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
- 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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|