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Inguinal Hernia Study Using Biodesign IHM

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biodesign IHM
Polypropylene mesh
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, polypropylene, Biodesign IHM, lichtenstein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Biodesign IHM Graft placement

Polypropylene mesh placement

Outcomes

Primary Outcome Measures

Number of Patients With Inguinal Hernia Recurrence

Secondary Outcome Measures

Full Information

First Posted
October 26, 2006
Last Updated
October 16, 2015
Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated, MED Institute, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00393887
Brief Title
Inguinal Hernia Study Using Biodesign IHM
Official Title
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated, MED Institute, Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal hernia, polypropylene, Biodesign IHM, lichtenstein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Biodesign IHM Graft placement
Arm Title
2
Arm Type
Active Comparator
Arm Description
Polypropylene mesh placement
Intervention Type
Device
Intervention Name(s)
Biodesign IHM
Other Intervention Name(s)
SurgiSIS IHM
Intervention Description
Biodesign IHM is placed to reinforce the hernia repair
Intervention Type
Device
Intervention Name(s)
Polypropylene mesh
Intervention Description
Polypropylene mesh is used to reinforce the hernia repair.
Primary Outcome Measure Information:
Title
Number of Patients With Inguinal Hernia Recurrence
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Timmons, M.D.
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24655865
Description
Biologic vs Synthetic Inguinal Hernia Repair: 1-year Results of a Randomized Double-Blinded Trial

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Inguinal Hernia Study Using Biodesign IHM

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