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

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.

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

Inclusion Criteria:

• wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
• incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
• incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
• incisional abdominal hernias requiring a surgical procedure
• incisional abdominal hernias amenable to repair with a single biological mesh
• age over 18 years

Exclusion Criteria:

• non-infected incisional abdominal hernia
• history of biological mesh placement
• incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
• incisional abdominal hernia larger than 20 x 20 cm
• BMI ≥ 40 kg/m2
• ASA score 4 and 5
• immunosuppression (including steroid and cytotoxic therapy)
• chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder
• life expectancy under than 36 months
• allergy to one of the biological mesh components
• pregnancy or breastfeeding