Ventral Hernia
Conditions
Keywords
incisional ventral hernia, infected field, biological mesh
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
Interventions
BIOLOGICALBiological 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.
PROCEDUREwithout 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
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month postoperative morbidity | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 1-year recurrent hernia rates | 1 year |
| postoperative pain | up to 3 years |
| quality of life | up to 3 years |
| time to cure | up to 3 years |
| need for wound reoperation due to infection or hernia recurrence | up to 3 years |
| impact of the cross-linked mesh structure on the primary objective | 6 months |
| medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment. | up to 3 years |
| Day 45 wound infection rate | 45 days |
| 1 year wound infection rate | 1 year |
| 2-year recurrent hernia rates | 2 years |
| 3-year recurrent hernia rates | 3 years |
| impact of the cross-linked mesh structure on the 1-year 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 |
| 3 months wound infection rate | 3 months |
Countries
France
Outcome results
None listed