Inguinal Hernia Study Using Biodesign IHM

Cook Group Incorporated100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Inguinal Hernia

Interventions

Biodesign IHMDEVICE

Biodesign IHM is placed to reinforce the hernia repair

Polypropylene meshDEVICE

Polypropylene mesh is used to reinforce the hernia repair.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number of Patients With Inguinal Hernia Recurrence

Time frame: 1 year

Data from ClinicalTrials.gov

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