CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 172 enrolled
Drug / intervention
Inguinal hernia repair with Ultrapro +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00681291
NCT00681291Phase 4Completed
CompareCT.gov

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

LifeCell·interventional·Posted May 21, 2008·Updated May 10, 2016

In Brief

A Phase 4 clinical trial evaluating Inguinal hernia repair with Ultrapro and Inguinal hernia repair with Strattice for Hernia, Inguinal. Completed, enrolled 172 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHernia, Inguinal
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.1 years ago

Interventions

Inguinal hernia repair with Ultraprodevice

surgical mesh (15x15cm) to support Lichtenstein repair

Inguinal hernia repair with Stratticedevice

Surgical mesh (10x16) used to support Lichtenstein repair