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OpenTrials
Completed

NCT Number: NCT00892333

Large Abdominal Hernia Repair With SurgiMend 3.0

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%.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Los Angeles County/University of Southern California Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hernia recurrence

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Boston Medical Center
  • Cook County Hospital
  • Massachusetts General Hospital
  • Oregon Health and Science University
  • State University of New York - Upstate Medical University
  • University of Southern California
  • Yale University

Registry information

Official study title

Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

Acronym: BRIDGE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 4, 2009
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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