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

Tracking Information
First Submitted Date  ICMJE October 26, 2006
First Posted Date  ICMJE October 29, 2006
Results First Submitted Date  ICMJE July 29, 2015
Results First Posted Date  ICMJE August 25, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2015)
Number of Patients With Inguinal Hernia Recurrence [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2006)
Recurrence rate
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2006)
Time back to baseline and complications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inguinal Hernia Study Using Biodesign IHM
Official Title  ICMJE Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Inguinal Hernia
Intervention  ICMJE
  • Device: Biodesign IHM
    Biodesign IHM is placed to reinforce the hernia repair
    Other Name: SurgiSIS IHM
  • Device: Polypropylene mesh
    Polypropylene mesh is used to reinforce the hernia repair.
Study Arms  ICMJE
  • Experimental: 1
    Biodesign IHM Graft placement
    Intervention: Device: Biodesign IHM
  • Active Comparator: 2
    Polypropylene mesh placement
    Intervention: Device: Polypropylene mesh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2006)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393887
Other Study ID Numbers  ICMJE H-28044
05-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cook Group Incorporated
Study Sponsor  ICMJE Cook Group Incorporated
Collaborators  ICMJE
  • Cook Biotech Incorporated
  • MED Institute, Incorporated
Investigators  ICMJE
Principal Investigator: Tracy Timmons, M.D. University of Maryland, College Park
PRS Account Cook Group Incorporated
Verification Date October 2015

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