Biological Meshes in Infected Fields: a Randomized Controlled Trial

Phase 3

Completed

• Conditions: Ventral Hernia

• 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

Study Timeline

• Study First Submitted: 2012-04-22
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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