COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Inguinal Hernia Study Using Biodesign IHM

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. Identifier: NCT00393887
Recruitment Status : Completed
First Posted : October 29, 2006
Results First Posted : August 25, 2015
Last Update Posted : November 20, 2015
Cook Biotech Incorporated
MED Institute, Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Inguinal Hernia Device: Biodesign IHM Device: Polypropylene mesh Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00393887

Layout table for location information
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Cook Group Incorporated
Cook Biotech Incorporated
MED Institute, Incorporated
Layout table for investigator information
Principal Investigator: Tracy Timmons, M.D. University of Maryland, College Park
Additional Information:
Layout table for additonal information
Responsible Party: Cook Group Incorporated Identifier: NCT00393887    
Other Study ID Numbers: H-28044
First Posted: October 29, 2006    Key Record Dates
Results First Posted: August 25, 2015
Last Update Posted: November 20, 2015
Last Verified: October 2015
Keywords provided by Cook Group Incorporated:
Inguinal hernia
Biodesign IHM
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal