Study of Surgical Mesh for Inguinal Hernia Repair - Full Text View

Sponsor:	Biomerix
Information provided by:	Biomerix
ClinicalTrials.gov Identifier:	NCT00924755

Purpose

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	Intervention	Phase
Hernia, Inguinal	Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Hernia

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione

U.S. FDA Resources

Further study details as provided by Biomerix:

Primary Outcome Measures:

Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hernia recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Pain and functional status [ Time Frame: 10 day, 6 weeks, 6 months 1 year ] [ Designated as safety issue: No ]
Incidence of complications [ Time Frame: 10 days, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	June 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Revive

Eligibility

Ages Eligible for Study:	19 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924755

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

No publications provided

Responsible Party:	Christina Kichula, Biomerix
ClinicalTrials.gov Identifier:	NCT00924755 History of Changes
Other Study ID Numbers:	BMX-2008-03
Study First Received:	June 17, 2009
Last Updated:	October 1, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomerix:

Surgical mesh

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on February 09, 2012