Biological Meshes in Infected Fields: a Randomized Controlled Trial

NCT01594450 | Completed Phase 3 DMC

• 2 other identifiers: 2011_562011-A00059-34
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

incisional ventral hernia; infected field; biological mesh

Outcome Measures

Primary Outcomes (1)

• 6-month postoperative morbidity

  6 months

Secondary Outcomes (15)

• 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

Study Arms (2)

biological mesh

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: Biological mesh

without biological mesh

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.

Procedure: without biological mesh

Interventions

Biological mesh BIOLOGICAL

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.

Also known as: Biologics, Acellular dermal matrix

biological mesh

without biological mesh PROCEDURE

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

Also known as: standard wound care

without biological mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Claude Huriez Hospital, University hospital

Lille, 59037, France

Location

Related Publications (1)

• 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.

  PMID: 23782773 RESULT

MeSH Terms

Conditions

Hernia, Ventral

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Guillaume Piessen, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2012
• First Posted: May 9, 2012
• Study Start: May 1, 2012
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: December 22, 2025

Record last verified: 2019-08

Locations

FR (1)