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Inguinal Hernia Study Using Biodesign IHM

NCT ID: NCT00393887

Last Updated: 2015-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Biodesign IHM Graft placement

Group Type EXPERIMENTAL

Biodesign IHM

Intervention Type DEVICE

Biodesign IHM is placed to reinforce the hernia repair

2

Polypropylene mesh placement

Group Type ACTIVE_COMPARATOR

Polypropylene mesh

Intervention Type DEVICE

Polypropylene mesh is used to reinforce the hernia repair.

Interventions

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Biodesign IHM

Biodesign IHM is placed to reinforce the hernia repair

Intervention Type DEVICE

Polypropylene mesh

Polypropylene mesh is used to reinforce the hernia repair.

Intervention Type DEVICE

Other Intervention Names

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SurgiSIS IHM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Biotech Incorporated

INDUSTRY

Sponsor Role collaborator

MED Institute, Incorporated

INDUSTRY

Sponsor Role collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy Timmons, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/24655865

Biologic vs Synthetic Inguinal Hernia Repair: 1-year Results of a Randomized Double-Blinded Trial

Other Identifiers

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05-003

Identifier Type: -

Identifier Source: secondary_id

H-28044

Identifier Type: -

Identifier Source: org_study_id