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

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Biological mesh
without biological mesh
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring incisional ventral hernia, infected field, biological mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Claude Huriez Hospital, University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

biological mesh

without biological mesh

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

6-month postoperative morbidity

Secondary Outcome Measures

Day 45 wound infection rate
1-year recurrent hernia rates
postoperative pain
quality of life
time to cure
need for wound reoperation due to infection or hernia recurrence
impact of the cross-linked mesh structure on the primary objective
medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.
3 months wound infection rate
1 year wound infection rate
2-year recurrent hernia rates
3-year recurrent hernia rates
impact of the cross-linked mesh structure on the 1-year infection rate
impact of the cross-linked mesh structure on the 1-year recurrence rate
impact of the cross-linked mesh structure on the 3-year recurrence rate

Full Information

First Posted
April 22, 2012
Last Updated
August 5, 2019
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01594450
Brief Title
Biological Meshes in Infected Fields: a Randomized Controlled Trial
Acronym
SIMBIOSE
Official Title
Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
incisional ventral hernia, infected field, biological mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
biological mesh
Arm Type
Experimental
Arm Description
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.
Arm Title
without biological mesh
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Biological mesh
Other Intervention Name(s)
Biologics, Acellular dermal matrix
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
without biological mesh
Other Intervention Name(s)
standard wound care
Intervention Description
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
Primary Outcome Measure Information:
Title
6-month postoperative morbidity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Day 45 wound infection rate
Time Frame
45 days
Title
1-year recurrent hernia rates
Time Frame
1 year
Title
postoperative pain
Time Frame
up to 3 years
Title
quality of life
Time Frame
up to 3 years
Title
time to cure
Time Frame
up to 3 years
Title
need for wound reoperation due to infection or hernia recurrence
Time Frame
up to 3 years
Title
impact of the cross-linked mesh structure on the primary objective
Time Frame
6 months
Title
medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.
Time Frame
up to 3 years
Title
3 months wound infection rate
Time Frame
3 months
Title
1 year wound infection rate
Time Frame
1 year
Title
2-year recurrent hernia rates
Time Frame
2 years
Title
3-year recurrent hernia rates
Time Frame
3 years
Title
impact of the cross-linked mesh structure on the 1-year infection rate
Time Frame
1 year
Title
impact of the cross-linked mesh structure on the 1-year recurrence rate
Time Frame
1 year
Title
impact of the cross-linked mesh structure on the 3-year recurrence rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Piessen, MD, PhD
Organizational Affiliation
Lille University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Claude Huriez Hospital, University hospital
City
Lille cedex
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23782773
Citation
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.
Results Reference
derived

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Biological Meshes in Infected Fields: a Randomized Controlled Trial

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