Strattice in Repair of Inguinal Hernias

Completed · Phase 4

Conditions studied: Hernia, Inguinal

In brief

This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.

Key facts

Study ID

NCT00681291

Run by

LifeCell

People needed

172

Starts

2008-04-01

Expected to finish

2012-06-01

Last updated by the study team

2016-05-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• adult male
• symptomatic and palpable inguinal hernia
• open, elective, primary unilateral inguinal hernia repair

You may not qualify if…

• 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

Where it is running

• Hospital of St Raphael — New Haven, Connecticut, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Creighton University — Omaha, Nebraska, United States
• Regional Surgical Associates — Durham, North Carolina, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Baylor College of Medicine — Houston, Texas, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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