Study of Surgical Mesh for Inguinal Hernia Repair

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hernia, Inguinal	Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	25 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
Study Start Date :	June 2009
Estimated Primary Completion Date :	October 2010
Estimated Study Completion Date :	November 2010

Arms and Interventions

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Intervention Details:

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

Outcome Measures

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Primary Outcome Measures :

1. Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. Hernia recurrence [ Time Frame: 1 year ]
2. Pain and functional status [ Time Frame: 10 day, 6 weeks, 6 months 1 year ]
3. Incidence of complications [ Time Frame: 10 days, 6 weeks, 6 months, 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Biomerix

Investigators

Principal Investigator:	Samir S Awad, MD	Baylor College of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Christina Kichula, Biomerix
ClinicalTrials.gov Identifier:	NCT00924755 History of Changes
Other Study ID Numbers:	BMX-2008-03
First Posted:	June 19, 2009
Last Update Posted:	October 4, 2010
Last Verified:	October 2010

Keywords provided by Biomerix:

Surgical mesh

Additional relevant MeSH terms:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal; Caffeine; Central Nervous System Stimulants; Physiological Effects of Drugs	Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents