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Hernia Repair in Multiply Morbid Patients

NCT ID: NCT00930787

Last Updated: 2013-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Ventral Hernia

Keywords

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hernia repair, surgical mesh, co-morbidities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Strattice Reconstructive Tissue Matrix

Use of Strattice Reconstructive Tissue Matrix to support hernia repair

Group Type EXPERIMENTAL

Strattice Reconstructive Tissue Matrix (Hernia Repair)

Intervention Type DEVICE

Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.

Proceed Surgical Mesh

Use of Proceed Surgical Mesh to support hernia repair

Group Type ACTIVE_COMPARATOR

Proceed Surgical Mesh (Hernia repair)

Intervention Type DEVICE

Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.

Interventions

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Strattice Reconstructive Tissue Matrix (Hernia Repair)

Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.

Intervention Type DEVICE

Proceed Surgical Mesh (Hernia repair)

Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeCell

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Martindale, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Louisiana Status University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Boston Veterans Administration Healthcare System

West Roxbury, Massachusetts, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Truman Medical Center

Kansas City, Missouri, United States

Site Status

Long Island Jewish - North Shore

Lake Success, New York, United States

Site Status

University Hospital - Case Western

Cleveland, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Scott & White Medical Center

Temple, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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LFC2007.03.01

Identifier Type: -

Identifier Source: org_study_id