Large Abdominal Hernia Repair With SurgiMend 3.0

NCT ID: NCT00892333

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-07-31

Brief Summary

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The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.

Detailed Description

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Conditions

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Hernia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All three of the following criteria must be present for enrollment into the study:

* Large abdominal hernia
* Inability to close the fascia primarily
* Contra-indication for the use of synthetic mesh
* Age \> 18 years

Exclusion Criteria

* Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique
* Inability to close the skin over the SurgiMend 3.0
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

Cook County Hospital

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George C Velmahos, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital/ Harvard University

Locations

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Los Angeles County/University of Southern California Medical Center

Los Angeles, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Cook County Hospital

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

State University of New York (SUNY), Upstate Medical Center

Syracuse, New York, United States

Site Status

Oklahoma University

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health and Science University (OHSU)

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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TEI-002

Identifier Type: -

Identifier Source: org_study_id

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