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

C. R. Bard

Status: Completed

Conditions: Hernia

Study type: Observational

Funder types: Industry

Identifiers

NCT01205399

DVL-HE006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

78 participants in 1 patient group

AlloMax Surgical Graft Group