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

This study is currently recruiting participants.
Verified April 2012 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01594450
First received: April 22, 2012
Last updated: November 7, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Ventral Hernia
 Biological: Biological mesh
Procedure: without biological mesh
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 6-month postoperative morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Day 45 wound infection rate [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
  • 1-year recurrent hernia rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • time to cure [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • need for wound reoperation due to infection or hernia recurrence [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • impact of the cross-linked mesh structure on the primary objective [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • 3 months wound infection rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 1 year wound infection rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 2-year recurrent hernia rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 3-year recurrent hernia rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • impact of the cross-linked mesh structure on the 1-year infection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • impact of the cross-linked mesh structure on the 1-year recurrence rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • impact of the cross-linked mesh structure on the 3-year recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Biologics
  • Acellular dermal matrix
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 Name: standard wound care

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594450

Contacts
Contact: CHRISTOPHE MARIETTE +33320444407 christophe.mariette@chru-lille.fr

Locations
France
Claude Huriez Hospital, University hospital Recruiting
Lille cedex, France, 59037
Contact: christophe mariette, MD, PhD     +33320444407     christophe.mariette@chru-lille.fr    
Principal Investigator: christophe mariette            
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Christophe Mariette, MD, PhD LILLE UNIVERSITY HOSPITAL
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01594450     History of Changes
Other Study ID Numbers: 2011-A00059-34, 2011_56
Study First Received: April 22, 2012
Last Updated: November 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
incisional ventral hernia
infected field
biological mesh

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 17, 2013