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Trial record 1 of 4 for:    infected ventral hernia biological mesh
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Biological Meshes in Infected Fields: a Randomized Controlled Trial (SIMBIOSE)

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ClinicalTrials.gov Identifier: NCT01594450
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Biological: Biological mesh Procedure: without biological mesh Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Actual Study Start Date : May 2012
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine


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:
  • 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




Primary Outcome Measures :
  1. 6-month postoperative morbidity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594450


Locations
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France
Claude Huriez Hospital, University hospital
Lille cedex, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Guillaume Piessen, MD, PhD Lille University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01594450    
Other Study ID Numbers: 2011_56
2011-A00059-34 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
incisional ventral hernia
infected field
biological mesh
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal