Biological Meshes in Infected Fields: a Randomized Controlled Trial (SIMBIOSE)

University Hospital, Lille

Status and phase: Completed; Phase 3

Conditions: Ventral Hernia

Treatments: Biological: Biological mesh; Procedure: without biological mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT01594450

2011-A00059-34 (Other Identifier)

2011_56

Details and patient eligibility

About

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.

Full description

Comparison between standard wound care and the use of biological meshes in infected fields

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

biological mesh

Experimental group

Description:

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.

Treatment:

Biological: Biological mesh

without biological mesh

Active Comparator group

Description:

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.

Treatment:

Procedure: without biological mesh