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Inguinal Hernia Study Using Surgisis IHM (SurgiSIS IHM)

This study has been completed.
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: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Inguinal Hernia
Device: Surgisis IHM
Device: Prolene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time back to baseline and complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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
Surgisis IHM Graft placement
Device: Surgisis IHM
Surgisis IHM is placed to reinforce the hernia repair
Other Name: SurgiSIS Biodesign
Active Comparator: 2
Polypropylene mesh placement
Device: Prolene
Prolene mesh is used to reinforce the hernia repair.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393887

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00393887     History of Changes
Other Study ID Numbers: H-28044, 05-003
Study First Received: October 26, 2006
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Inguinal hernia
polypropylene
Surgisis IHM
lichtenstein

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

ClinicalTrials.gov processed this record on November 24, 2014