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NCT Number: NCT01594450

Biological Meshes in Infected Fields: a Randomized Controlled Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Claude Huriez Hospital, University hospital

Lille, 59037, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Biologics, Acellular dermal matrix

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

Other names: standard wound care

Primary outcomes

  1. 6-month postoperative morbidity

    Time frame: 6 months

Secondary outcomes

  1. Day 45 wound infection rate

    Time frame: 45 days

  2. 1-year recurrent hernia rates

    Time frame: 1 year

  3. postoperative pain

    Time frame: up to 3 years

  4. quality of life

    Time frame: up to 3 years

  5. time to cure

    Time frame: up to 3 years

  6. need for wound reoperation due to infection or hernia recurrence

    Time frame: up to 3 years

  7. impact of the cross-linked mesh structure on the primary objective

    Time frame: 6 months

  8. medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.

    Time frame: up to 3 years

  9. 3 months wound infection rate

    Time frame: 3 months

  10. 1 year wound infection rate

    Time frame: 1 year

  11. 2-year recurrent hernia rates

    Time frame: 2 years

  12. 3-year recurrent hernia rates

    Time frame: 3 years

  13. impact of the cross-linked mesh structure on the 1-year infection rate

    Time frame: 1 year

  14. impact of the cross-linked mesh structure on the 1-year recurrence rate

    Time frame: 1 year

  15. impact of the cross-linked mesh structure on the 3-year recurrence rate

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: SIMBIOSE

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 9, 2012
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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