Biological Meshes in Infected Fields: a Randomized Controlled Trial

Ventral Hernia Clinical Trial

— SIMBIOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594450
• Other study ID #: 2011_56
• Secondary ID: 2011-A00059-34
• Status: Completed
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: March 28, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

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.

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

Locations

Country	Name	City	State
France	Claude Huriez Hospital, University hospital	Lille cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month postoperative morbidity		6 months
Secondary	Day 45 wound infection rate		45 days
Secondary	1-year recurrent hernia rates		1 year
Secondary	postoperative pain		up to 3 years
Secondary	quality of life		up to 3 years
Secondary	time to cure		up to 3 years
Secondary	need for wound reoperation due to infection or hernia recurrence		up to 3 years
Secondary	impact of the cross-linked mesh structure on the primary objective		6 months
Secondary	medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.		up to 3 years
Secondary	3 months wound infection rate		3 months
Secondary	1 year wound infection rate		1 year
Secondary	2-year recurrent hernia rates		2 years
Secondary	3-year recurrent hernia rates		3 years
Secondary	impact of the cross-linked mesh structure on the 1-year infection rate		1 year
Secondary	impact of the cross-linked mesh structure on the 1-year recurrence rate		1 year
Secondary	impact of the cross-linked mesh structure on the 3-year recurrence rate		3 years