Study of Surgical Mesh for Inguinal Hernia Repair

Phase 4

• Conditions: Hernia, Inguinal

• Registration Number: NCT00924755
• Lead Sponsor: Biomerix

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Last Update Submitted: 2010-10-01
• Last Update Posted: 2010-10-04
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Technical success with no complications through 6 weeks.	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Michael E. DeBakey Veterans Affairs Medical Center; 🇺🇸 Houston, Texas, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States