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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Biological: Biological mesh; Procedure: without biological mesh

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lille cedex, France, 59037
    • Claude Huriez Hospital, University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: biological mesh; 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; 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.; Other Names: Acellular dermal matrix; Biologics
ACTIVE_COMPARATOR: without biological mesh; 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; 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; Other Names: standard wound care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-month postoperative morbidity	6 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Guillaume Piessen, MD, PhD, Lille University Hospital

Publications and helpful links

General Publications

• Mariette C, Briez N, Denies F, Dervaux B, Duhamel A, Guilbert M, Bruyere E, Robb WB, Piessen G; FRENCH. Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial. Trials. 2013 May 7;14:131. doi: 10.1186/1745-6215-14-131.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2012
• Primary Completion (ACTUAL): March 28, 2019
• Study Completion (ACTUAL): March 28, 2019

Study Registration Dates

• First Submitted: April 22, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (ESTIMATE): May 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: biological mesh; incisional ventral hernia; infected field
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 2011_56; 2011-A00059-34 (OTHER: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No