NCT01205399

A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hernia

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-09-20
• Last updated: 2017-01-18
• Results posted: 2012-08-23

Locations

5 sites across 1 country: United States