Large Abdominal Hernia Repair With SurgiMend 3.0

Hernia Clinical Trial

— BRIDGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892333
• Other study ID #: TEI-002
• Status: Completed
• Phase: N/A
• First received: April 29, 2009
• Last updated: May 16, 2016
• Start date: April 2009
• Est. completion date: July 2014

Study information

• Verified date: May 2016
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cook County Hospital	Chicago	Illinois
United States	Los Angeles County/University of Southern California Medical Center	Los Angeles	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Oklahoma University	Oklahoma City	Oklahoma
United States	Oregon Health and Science University (OHSU)	Portland	Oregon
United States	State University of New York (SUNY), Upstate Medical Center	Syracuse	New York

Sponsors (8)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence		1 year	No