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.
Primary Outcome Measures:
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| 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.