Abstract

In this work, silicone elastomer films with potential to be used as implantable pelvic prosthesis were prepared and their bioactivity was studied both in vitro and in vivo environment. Tensile tests, hardness measurement and compression analysis revealed no significant decrease of the mechanical performance after in vitro hydrolytic degradation in simulated body fluids. The in vivo biocompatibility of films was assessed by implanting them subcutaneously in swine model, for 30 days. Their mechanical characteristics were similar to those of samples immersed in simulated body fluids, for the same time interval. No sign of fibrosis or necrosis were detected from the histological analysis performed on the tissue surrounding the films. In combination, these results indicate that this material has a very good resistance to mechanical and chemical fatigue, do not release any toxic degradation products and, therefore, has great potential as to be used further for preparation of pelvic prosthesis.

Highlights

  • The incidence of cancer is growing worldwide, and the number of oncological surgeries, including pelvic exenteration for advanced tumors is increasing

  • We proved that Elastosil LR 3003/40 can be considered a material of choice for the development of pelvic prosthesis, from the point of view of mechanical strength, even without reinforcing [18]

  • In this study we focused on the host tissue response in contact with films made of neat silicone elastomer and the ability of this material to keep its mechanical performance in a living organism

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Summary

Introduction

The incidence of cancer is growing worldwide, and the number of oncological surgeries, including pelvic exenteration for advanced tumors is increasing. Pelvic exenteration is an extensive surgical technique that involves en bloc resection of the pelvic organs, including the bladder, internal reproductive organs and the rectosigmoid This procedure aims to cure advanced primary or recurrent cancers confined to the pelvis. Local complications are favored by the remaining empty space in the exenterated pelvis in which intraabdominal organs can migrate, especially small bowel loops They include infections, pelvic collections, anastomotic leaks or fistulae, adhesions, bowel obstruction, urinary obstruction, wound complications etc. Current surgical techniques that aim to reduce the remaining space consist of importing healthy tissues into the exenterated pelvis [3] Examples of such techniques are omental flaps [1], local advancement, rotation flaps and pedicled musculocutaneous flaps that use the rectus abdominis, the gluteal or the gracilis muscles [3]. To the best of our knowledge, no study concerning the use of silicone elastomers as long term intraperitoneal implants has been reported in literature up to now

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