NCT01594450

Biological Meshes in Infected Fields: a Randomized Controlled Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
BIOLOGICAL	Biological mesh	patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.
PROCEDURE	without biological mesh	patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization In cases of treatment failure at 6 months, patients of arm B are allowed to undergo any treatment which the treating surgeon views suitable, including a surgical procedure with implantation of a biological mesh

Timeline

• Start date: 2012-05-01
• Primary completion: 2019-03-28
• Completion: 2019-03-28
• First posted: 2012-05-09
• Last updated: 2025-12-22

Locations

1 site across 1 country: France