Biological Meshes in Infected Fields: a Randomized Controlled Trial (SIMBIOSE)
Ventral Hernia
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring incisional ventral hernia, infected field, biological mesh
Eligibility Criteria
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
Sites / Locations
- Claude Huriez Hospital, University hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
biological mesh
without 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.
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.