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Inguinal Hernia Study Using Surgisis IHM (SurgiSIS IHM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cook Biotech Incorporated
MED Institute, Incorporated
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00393887
First received: October 26, 2006
Last updated: December 21, 2012
Last verified: December 2012
History of Changes

October 26, 2006
December 21, 2012
March 2007
February 2014   (final data collection date for primary outcome measure)
Recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Recurrence rate
Complete list of historical versions of study NCT00393887 on ClinicalTrials.gov Archive Site
Time back to baseline and complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Time back to baseline and complications
Not Provided
Not Provided
 
Inguinal Hernia Study Using Surgisis IHM
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Surgisis IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Outcomes are recurrence, return to full activities, pain, seroma rates and complications. Patients will be followed at 2 weeks, 3 months, and 6 months post-operatively, and every 6 months after that for 3 years. Hernia recurrence will be confirmed via ultrasound or CT scan.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia
  • Device: Surgisis IHM
    Surgisis IHM is placed to reinforce the hernia repair
    Other Name: SurgiSIS Biodesign
  • Device: Prolene
    Prolene mesh is used to reinforce the hernia repair.
  • Experimental: 1
    Surgisis IHM Graft placement
    Intervention: Device: Surgisis IHM
  • Active Comparator: 2
    Polypropylene mesh placement
    Intervention: Device: Prolene
Not Provided

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

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00393887
H-28044, 05-003
No
Cook
Cook
  • Cook Biotech Incorporated
  • MED Institute, Incorporated
Principal Investigator: Ajay Jain, M.D. University of Maryland
Cook
December 2012

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