A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft|
- Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft [ Time Frame: 9 + Months ] [ Designated as safety issue: No ]A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.
- Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. [ Time Frame: 9+ Months ] [ Designated as safety issue: Yes ]Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit.
- Procedural Time for AlloMax Surgical Graft Placement. [ Time Frame: 0 Days ] [ Designated as safety issue: No ]Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).
|Study Start Date:||September 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|AlloMax Surgical Graft Group|
Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205399
|United States, Kentucky|
|University of Kentucky Medical Center|
|Lexington, Kentucky, United States, 40536|
|United States, Missouri|
|Benrus Surgical Associates, Inc|
|Saint Peters, Missouri, United States, 63376|
|United States, New York|
|Winthrop Surgical Associates, Inc.|
|Mineola, New York, United States, 11501|
|United States, Oklahoma|
|Surgical Associates, Inc.|
|Tulsa, Oklahoma, United States, 74136|
|United States, Pennsylvania|
|Golla Center for Plastic Surgery|
|Pittsburg, Pennsylvania, United States, 15238|
|Principal Investigator:||John S Roth, MD||University of Kentucky|