Study of Surgical Mesh for Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00924755
• Other study ID #: BMX-2008-03
• Status: Unknown status
• Phase: Phase 4
• First received: June 17, 2009
• Last updated: October 1, 2010
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2010
• Source: Biomerix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 25
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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

Locations

Country	Name	City	State
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Biomerix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success with no complications through 6 weeks.		6 weeks
Secondary	Hernia recurrence		1 year
Secondary	Pain and functional status		10 day, 6 weeks, 6 months 1 year
Secondary	Incidence of complications		10 days, 6 weeks, 6 months, 1 year