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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
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 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
Claude Huriez Hospital, University hospital
Lille, France
6-month postoperative morbidity
Time frame: 6 months
Day 45 wound infection rate
Time frame: 45 days
1-year recurrent hernia rates
Time frame: 1 year
postoperative pain
Time frame: up to 3 years
quality of life
Time frame: up to 3 years
time to cure
Time frame: up to 3 years
need for wound reoperation due to infection or hernia recurrence
Time frame: up to 3 years
impact of the cross-linked mesh structure on the primary objective
Time frame: 6 months
medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.
Time frame: up to 3 years
3 months wound infection rate
Time frame: 3 months
1 year wound infection rate
Time frame: 1 year
2-year recurrent hernia rates
Time frame: 2 years
3-year recurrent hernia rates
Time frame: 3 years
impact of the cross-linked mesh structure on the 1-year infection rate
Time frame: 1 year
impact of the cross-linked mesh structure on the 1-year recurrence rate
Time frame: 1 year
impact of the cross-linked mesh structure on the 3-year recurrence rate
Time frame: 3 years
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