Open Access Study protocol

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

Christophe Mariette1236*, Nicolas Briez12, Fanette Denies4, Benoît Dervaux25, Alain Duhamel25, Marie Guilbert1, Emilie Bruyère1, William B Robb1, Guillaume Piessen123 and on behalf of FRENCH

Author Affiliations

1 Department of Digestive and Oncological Surgery, University Hospital of Lille, Place de Verdun, Lille Cedex, 59037, France

2 University Lille Nord de France, Place de Verdun, Lille Cedex, 59045, France

3 Inserm UMR 837, Team 5 Mucins, Epithelial Differentiation and Carcinogenesis, JPARC, Rue Polonovski, Lille Cedex, 59045, France

4 Hospital Pharmacy, University Hospital of Lille, Place de Verdun, Lille Cedex, 59037, France

5 Department of Biostatistics and Public Health, University Hospital of Lille, Place de Verdun, Lille Cedex, 59037, France

6 Department of Digestive and Oncological Surgery, University Hospital Claude Huriez, Regional University Hospital Center, Place de Verdun, Lille Cedex, 59037, France

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Trials 2013, 14:131  doi:10.1186/1745-6215-14-131

Published: 7 May 2013

Abstract

Background

In infected incisional ventral hernias (IVHs), the use of a synthetic non-absorbable mesh is not recommended and biological meshes hold promise. However, the level of evidence for their safety and efficacy remains low.

Methods

The SIMBIOSE trial is a multicenter, phase III, randomized, controlled trial comparing the use of a biological mesh versus traditional wound care in patients with an IVH. The primary end point is 6-month infectious and/or wound morbidity. Secondary end points are wound infection and recurrent hernia rates, post-operative pain, quality of life, time to heal, reoperation need, impact of the cross-linked mesh structure, and a medico-economic evaluation. One hundred patients need to be included.

Results

The main results expected with biological mesh use are a significant decrease of post-operative morbidity, hernia recurrence, time to heal, and costs with an improved quality of life.

Conclusions

For the first time, the impact of biological meshes in the treatment of IVHs will be evaluated in an academic, randomized, phase III trial to provide scientific evidence ( NCT01594450).

Trial registration

ClinicalTrial.gov, NCT01594450

Keywords:
Incisional ventral hernia; Infection; Biological mesh; Randomized trial