Status:
COMPLETED
Strattice in Repair of Inguinal Hernias
Lead Sponsor:
LifeCell
Conditions:
Hernia, Inguinal
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance...
Eligibility Criteria
Inclusion
- adult male
- symptomatic and palpable inguinal hernia
- open, elective, primary unilateral inguinal hernia repair
Exclusion
- bilateral inguinal hernia repair
- BMI \>35
- chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD
- chronic prostatitis, orchitis, testicular pain
- local or systemic infection at time of repair
- known collagen disorder
- chronic pain syndrome or under active pain management
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00681291
Start Date
April 1 2008
End Date
June 1 2012
Last Update
May 10 2016
Active Locations (8)
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1
Hospital of St Raphael
New Haven, Connecticut, United States, 06511
2
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
3
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
4
Creighton University
Omaha, Nebraska, United States, 68178