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Large Abdominal Hernia Repair With SurgiMend 3.0 (BRIDGE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00892333
First Posted: May 4, 2009
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
Boston Medical Center
Cook County Hospital
University of Southern California
Yale University
Oregon Health and Science University
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Integra LifeSciences Corporation
  Purpose
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%.

Condition
Hernia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Hernia recurrence [ Time Frame: 1 year ]

Enrollment: 122
Study Start Date: April 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with surgical conditions such as i) open abdomen after a damage control operation for a traumatic or non-traumatic surgical emergency, ii) removal of infected prosthetic materials from a previous abdominal hernia repair, iii) iatrogenic injury of the bowel during adhisiolysis for repair of a large abdominal hernia, iv) contaminated operative field due to presence of an ostomy or the need for additional surgical procedures.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892333


Locations
United States, California
Los Angeles County/University of Southern California Medical Center
Los Angeles, California, United States, 90033
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Illinois
Cook County Hospital
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
State University of New York (SUNY), Upstate Medical Center
Syracuse, New York, United States, 13210
United States, Oklahoma
Oklahoma University
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
Oregon Health and Science University (OHSU)
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Integra LifeSciences Corporation
Massachusetts General Hospital
Boston Medical Center
Cook County Hospital
University of Southern California
Yale University
Oregon Health and Science University
State University of New York - Upstate Medical University
Investigators
Principal Investigator: George C Velmahos, MD, Ph.D. Massachusetts General Hospital/ Harvard University
  More Information

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00892333     History of Changes
Other Study ID Numbers: TEI-002
First Submitted: April 29, 2009
First Posted: May 4, 2009
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Integra LifeSciences Corporation:
Repair of a large hernia with SurgiMend 3.0, a biologic mesh

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical