Hernia Repair in Multiply Morbid Patients

Phase 4

Terminated

• Conditions: Ventral Hernia

• Registration Number: NCT00930787
• Lead Sponsor: LifeCell

Brief Summary

Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Study Start: 2009-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2012-08-16
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-17
• Last Update Submitted: 2013-09-17
• Results First Posted: 2013-11-20
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Adults of either gender
• must have 2 or more co-morbidities

Exclusion Criteria

• local or systemic infection
• expected survival of <24 months
• non-ambulatory

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Events (SSEs)	Postoperative Day 30

Trial Locations

Locations (13)

Louisiana Status University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Boston Veterans Administration Healthcare System; 🇺🇸 West Roxbury, Massachusetts, United States

Hurley Medical Center; 🇺🇸 Flint, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States

Long Island Jewish - North Shore; 🇺🇸 Lake Success, New York, United States

University Hospital - Case Western; 🇺🇸 Cleveland, Ohio, United States

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