Hernia Repair in Multiply Morbid Patients

Phase 4

Terminated

• Conditions: Ventral Hernia
• Interventions: Device: Strattice Reconstructive Tissue Matrix (Hernia Repair); Device: Proceed Surgical Mesh (Hernia repair)

• 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

Arm && Interventions

Group	Intervention	Description
Strattice Reconstructive Tissue Matrix	Strattice Reconstructive Tissue Matrix (Hernia Repair)	Use of Strattice Reconstructive Tissue Matrix to support hernia repair
Proceed Surgical Mesh	Proceed Surgical Mesh (Hernia repair)	Use of Proceed Surgical Mesh to support hernia repair

Primary Outcome Measures

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

Trial Locations

Locations (13)

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

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

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

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

Scott & White Medical Center; 🇺🇸 Temple, Texas, United States

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

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

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

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

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

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

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

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