Study of Surgical Mesh for Inguinal Hernia Repair

Study Overview
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Brief Summary
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The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.

Official Title
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Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male ≥19 years old symptomatic and palpable inguinal hernia candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique will comply with required follow-up study visits willing and able to provide written informed consent Exclusion Criteria: BMI ≥35 life expectancy of <3 years strangulated hernia urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery) active abdominal surgical condition such as bowel obstruction or perforation local or systemic infection or peritonitis known disease that impairs wound healing anti-platelet therapy (other than aspirin) for >7 days preceding the surgical procedure previous ipsilateral groin incision receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8 advanced cirrhosis with Child-Turcott Class of C or higher severe COPD requiring home oxygen diagnosed with chronic pain syndrome or is undergoing treatment for pain management candidate for another major surgical procedure with the inguinal hernia repair enrolled in another investigational study that may confound the results of this study known drug abuser on anti-psychotic medications Worker's Compensation case

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)|Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success with no complications through 6 weeks. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence |  | 1 year | 
| Pain and functional status |  | 10 day, 6 weeks, 6 months 1 year | 
| Incidence of complications |  | 10 days, 6 weeks, 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical mesh