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

N/ACompletedNCT01205399

C. R. Bard78 enrolled

Overview

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 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hernia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft

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.

Time frame: 9 + Months

Secondary Outcomes

Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.

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.

Time frame: 9+ Months

Procedural Time for AlloMax Surgical Graft Placement.

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).

Time frame: 0 Days