Biological Meshes in Infected Fields: a Randomized Controlled Trial

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

• Biological mesh (Biological), also known as Biologics, Acellular dermal matrix: 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.
• without biological mesh (Procedure), also known as standard wound care: 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 outcomes

• 6-month postoperative morbidity [6 months]

Secondary outcomes

• Day 45 wound infection rate [45 days]
• 1-year recurrent hernia rates [1 year]
• postoperative pain [up to 3 years]
• quality of life [up to 3 years]
• time to cure [up to 3 years]
• need for wound reoperation due to infection or hernia recurrence [up to 3 years]
• impact of the cross-linked mesh structure on the primary objective [6 months]
• medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment. [up to 3 years]
• 3 months wound infection rate [3 months]
• 1 year wound infection rate [1 year]
• 2-year recurrent hernia rates [2 years]
• 3-year recurrent hernia rates [3 years]
• impact of the cross-linked mesh structure on the 1-year infection rate [1 year]
• impact of the cross-linked mesh structure on the 1-year recurrence rate [1 year]
• impact of the cross-linked mesh structure on the 3-year recurrence rate [3 years]

Sex: All, ages: 18 Years to any

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

• Results publication: 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. PMID 23782773

• Guillaume Piessen, MD, PhD, Principal investigator, University Hospital, Lille