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Your journey
1What's a trial
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3Review
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More info
You can access this
clinical trial
if you have
Ventral Hernia
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Biological: Biological mesh
  • Procedure: without biological mesh

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01594450. The sponsor of the trial is University Hospital, Lille and it is looking for 110 volunteers for the current phase.
Official trial title:
Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study