Biological Meshes in Infected Fields: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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Comparison between standard wound care and the use of biological meshes in infected fields

Official Title
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Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study

Conditions
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Ventral Hernia

Intervention / Treatment
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* Biological: Biological mesh
* Procedure: without biological mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biological mesh<br>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. | Biological: Biological mesh<br>* 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.<br>* Other names: Acellular dermal matrix;|
| Active Comparator: without biological mesh<br>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. | Procedure: without biological mesh<br>* 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<br>* Other names: standard wound care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month postoperative morbidity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day 45 wound infection rate |  | 45 days | 
| 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 | 
| 3 months wound infection rate |  | 3 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incisional ventral hernia, infected field, biological mesh