CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 253 enrolled
Drug / intervention
Davol Bard Soft Mesh synthetic +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/NCT02451176
NCT02451176N/ACompleted
CompareCT.gov

A Prospective Randomized Trial of Biologic Mesh Versus Synthetic Mesh for the Repair of Complex Ventral Hernias

Michael Rosen·interventional·Posted May 21, 2015·Updated Sep 7, 2022

In Brief

A clinical study evaluating Davol Bard Soft Mesh synthetic and LifeCell Strattice Reconstructive Tissue Biologic for Ventral Hernia. Completed, enrolled 253 participants across 4 sites.

Detailed Summary

This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of this study will have a major impact on the field of hernia surgery as it will provide objective guide to mesh selection, optimize surgical approaches for complex ventral hernia repair, and ultimately significantly improve patient outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentral Hernia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 21, 2015
Enrollment StartApr 1, 2015
Primary CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 11.1 years ago

Interventions

Davol Bard Soft Mesh syntheticdevice

soft mesh synthetic

LifeCell Strattice Reconstructive Tissue Biologicdevice

biologic mesh