Biological Meshes in Infected Fields: a Randomized Controlled Trial
- Conditions
- Ventral Hernia
- Interventions
- Procedure: without biological meshBiological: Biological mesh
- Registration Number
- NCT01594450
- Lead Sponsor
- University Hospital, Lille
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description without biological mesh 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. biological mesh 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.
- Primary Outcome Measures
Name Time Method 6-month postoperative morbidity 6 months
- Secondary Outcome Measures
Name Time Method time to cure up to 3 years need for wound reoperation due to infection or hernia recurrence up to 3 years Day 45 wound infection rate 45 days 3 months wound infection rate 3 months 1 year wound infection rate 1 year impact of the cross-linked mesh structure on the 1-year recurrence rate 1 year impact of the cross-linked mesh structure on the 3-year recurrence rate 3 years impact of the cross-linked mesh structure on the primary objective 6 months postoperative pain up to 3 years 2-year recurrent hernia rates 2 years 3-year recurrent hernia rates 3 years 1-year recurrent hernia rates 1 year quality of life up to 3 years medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment. up to 3 years impact of the cross-linked mesh structure on the 1-year infection rate 1 year
Trial Locations
- Locations (1)
Claude Huriez Hospital, University hospital
🇫🇷Lille cedex, France