Large Abdominal Hernia Repair With SurgiMend 3.0 (BRIDGE)

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

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%.

Study Overview

• Status: Completed
• Conditions: Hernia

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County/University of Southern California Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Cook County Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • Syracuse, New York, United States, 13210
      • State University of New York (SUNY), Upstate Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • Oklahoma University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University (OHSU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hernia recurrence	1 year

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Massachusetts General Hospital; Yale University; University of Southern California; Boston Medical Center; Oregon Health and Science University; State University of New York - Upstate Medical University; Cook County Hospital
• Investigators: Principal Investigator: George C Velmahos, MD, Ph.D., Massachusetts General Hospital/ Harvard University

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 29, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): May 4, 2009

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Repair of a large hernia with SurgiMend 3.0, a biologic mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: TEI-002