Clinical trial NCT01594450: Biological Meshes in Infected Fields: a Randomized Controlled Trial
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventral Hernia
Keywords: incisional ventral hernia
infected field
biological mesh
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 6-month postoperative morbidity
timeFrame: 6 months
Secondary outcomes:
measure: Day 45 wound infection rate
timeFrame: 45 days
measure: 1-year recurrent hernia rates
timeFrame: 1 year
measure: postoperative pain
timeFrame: up to 3 years
measure: quality of life
timeFrame: up to 3 years
measure: time to cure
timeFrame: up to 3 years
measure: need for wound reoperation due to infection or hernia recurrence
timeFrame: up to 3 years
measure: impact of the cross-linked mesh structure on the primary objective
timeFrame: 6 months
measure: medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.
timeFrame: up to 3 years
measure: 3 months wound infection rate
timeFrame: 3 months
measure: 1 year wound infection rate
timeFrame: 1 year
measure: 2-year recurrent hernia rates
timeFrame: 2 years
measure: 3-year recurrent hernia rates
timeFrame: 3 years
measure: impact of the cross-linked mesh structure on the 1-year infection rate
timeFrame: 1 year
measure: impact of the cross-linked mesh structure on the 1-year recurrence rate
timeFrame: 1 year
measure: impact of the cross-linked mesh structure on the 3-year recurrence rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Lille cedex
country: France
facility: Claude Huriez Hospital, University hospital
Study officials:
affiliation: Lille University Hospital
name: Guillaume Piessen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.