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

Completed

Conditions studied: Hernia

In brief

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.

Key facts

Study ID

NCT01205399

Run by

C. R. Bard

People needed

78

Starts

2010-09-01

Expected to finish

2011-10-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
• Have signed an informed consent form (ICF).

You may not qualify if…

• Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
• June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Benrus Surgical Associates, Inc — City of Saint Peters, Missouri, United States
• Winthrop Surgical Associates, Inc. — Mineola, New York, United States
• Surgical Associates, Inc. — Tulsa, Oklahoma, United States
• Golla Center for Plastic Surgery — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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