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Large Abdominal Hernia Repair With SurgiMend 3.0

NCT00892333 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2016-05-17

No results posted yet for this study

Summary

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%.

Conditions

  • Hernia

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Boston Medical Center

    collaborator OTHER

  • Cook County Hospital

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • State University of New York - Upstate Medical University

    collaborator OTHER

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • George C Velmahos, MD, Ph.D. · Massachusetts General Hospital/ Harvard University

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892333 on ClinicalTrials.gov