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Biological Meshes in Infected Fields: a Randomized Controlled Trial — SIMBIOSE  

Ventral Hernia Clinical Trial

Official title:
Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study

Clinical Trial Summary

The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.

Clinical Trial Description

Comparison between standard wound care and the use of biological meshes in infected fields ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01594450
Study type Interventional
Source University Hospital, Lille
Contact
Status Completed
Phase Phase 3
Start date May 2012
Completion date March 28, 2019
View Details
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