NCT00924755UnknownPhase 4
Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Biomerix
- Enrollment
- 25
- Locations
- 4
- Primary Endpoint
- Technical success with no complications through 6 weeks.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Technical success with no complications through 6 weeks.
Time Frame: 6 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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