Overview

This trial is active, not recruiting.

Condition ventral hernia
Treatments biological mesh, without biological mesh
Phase phase 3
Sponsor University Hospital, Lille
Start date May 2012
End date April 2018
Trial size 110 participants
Trial identifier NCT01594450, 2011-A00059-34, 2011_56

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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 mesh Biologics
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.
(Active Comparator)
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.
without biological mesh standard wound care
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

Primary Outcomes

Measure
6-month postoperative morbidity
time frame: 6 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study
Principal investigator Christophe Mariette, MD, PhD
Description Comparison between standard wound care and the use of biological meshes in infected fields
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University Hospital, Lille.