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Trials / Completed

CompletedNCT00681291

Strattice in Repair of Inguinal Hernias

Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
172 (actual)
Sponsor
LifeCell · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
DEVICEInguinal hernia repair with Ultraprosurgical mesh (15x15cm) to support Lichtenstein repair
DEVICEInguinal hernia repair with StratticeSurgical mesh (10x16) used to support Lichtenstein repair

Timeline

Start date
2008-04-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2008-05-21
Last updated
2016-05-10
Results posted
2016-03-23

Locations

8 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00681291. Inclusion in this directory is not an endorsement.

Strattice in Repair of Inguinal Hernias (NCT00681291) · Clinical Trials Directory