Large Abdominal Hernia Repair With SurgiMend 3.0 (BRIDGE)

This study is ongoing, but not recruiting participants.
Sponsor:
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):
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT00892333
First received: April 29, 2009
Last updated: September 27, 2013
Last verified: September 2013

April 29, 2009
September 27, 2013
April 2009
September 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00892333 on ClinicalTrials.gov Archive Site
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Large Abdominal Hernia Repair With SurgiMend 3.0
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%.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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.

Hernia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00892333
TEI-002
No
TEI Biosciences Inc.
TEI Biosciences Inc.
  • 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
Principal Investigator: George C Velmahos, MD, Ph.D. Massachusetts General Hospital/ Harvard University
TEI Biosciences Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP