Study of Surgical Mesh for Inguinal Hernia Repair

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00924755

Enrollment

Registered

2009-06-19

Start date

2009-06-30

Completion date

2010-11-30

Last updated

2010-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

Surgical mesh

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.

Interventions

DEVICEBiomerix Revive™ (surgical mesh for inguinal hernia repair)

Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Technical success with no complications through 6 weeks.	6 weeks

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026