Inguinal Hernia Study Using Biodesign IHM

Cook Group

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: Biodesign IHM; Device: Polypropylene mesh

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393887

H-28044

05-003

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

Biodesign IHM Graft placement

Treatment:

Device: Biodesign IHM

2

Active Comparator group

Description:

Polypropylene mesh placement

Treatment:

Device: Polypropylene mesh