MedTrace Logo

Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias

NCT02451176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2022-09-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Ventral Hernia

Interventions

DEVICE

Davol Bard Soft Mesh synthetic

soft mesh synthetic

DEVICE

LifeCell Strattice Reconstructive Tissue Biologic

biologic mesh

Sponsors & Collaborators

  • Michael Rosen

    lead OTHER

Principal Investigators

  • Michael Rosen, MD · Cleveland Clinic, Cleveland, Ohio, United States, 44195

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451176 on ClinicalTrials.gov