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

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.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky Medical Center, Lexington, Kentucky, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 9 + Months

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.

Secondary outcomes

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

Time frame: 9+ Months

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

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).

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Acronym: AlloMax

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Sep 20, 2010
Registry last updated: Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed