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Inguinal Hernia Study Using Biodesign IHM

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00393887
First Posted: October 30, 2006
Last Update Posted: November 20, 2015
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:
Cook Biotech Incorporated
MED Institute, Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

Condition Intervention
Inguinal Hernia Device: Biodesign IHM Device: Polypropylene mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Number of Patients With Inguinal Hernia Recurrence [ Time Frame: 1 year ]

Enrollment: 100
Study Start Date: March 2007
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Biodesign IHM Graft placement
Device: Biodesign IHM
Biodesign IHM is placed to reinforce the hernia repair
Other Name: SurgiSIS IHM
Active Comparator: 2
Polypropylene mesh placement
Device: Polypropylene mesh
Polypropylene mesh is used to reinforce the hernia repair.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age
  • Diagnosis of Unilateral inguinal hernia repair
  • Able to provide written consent

Exclusion Criteria:

  • Incarcerated hernia
  • Allergic or religious beliefs that disallow porcine material
  • Previous hernia repair on the designated hernia site
  • Class IV or V anesthesia requirements
  • Bowel obstruction
  • Peritonitis
  • Life expectancy < 3 years
  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): NCT00393887


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Cook Group Incorporated
Cook Biotech Incorporated
MED Institute, Incorporated
Investigators
Principal Investigator: Tracy Timmons, M.D. University of Maryland
  More Information

Additional Information:
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00393887     History of Changes
Other Study ID Numbers: H-28044
05-003
First Submitted: October 26, 2006
First Posted: October 30, 2006
Results First Submitted: July 29, 2015
Results First Posted: August 25, 2015
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by Cook Group Incorporated:
Inguinal hernia
polypropylene
Biodesign IHM
lichtenstein

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