SILKELASTOGRAFT project is founded on 4 main activities:
- A comprehensive investigation in an animal model (rat) of the hypothesis that graft-vessel compliance matching leads to improved outcomes in terms of reduced thromboreactivity and stenosis. Differently from other studies, where the graft’s mechanical properties cannot be independently investigated from its bioactivity.
- A thorough in silico characterization of graft-vessel interactions, whose outcomes (wall mechanical stresses and fluid-dynamic shear stresses associated to various experimental conditions) will be compared and correlated with the outputs of the in vivo study, in order to identify a grading of the most critical factors leading to graft failure.
- A toolset for the estimation of diameter and compliance of forearm vessels in patients candidate for grafting. The system, which would be characterized by extreme simplicity, would enable – for the first time – the pre-operative characterization of the single patient’s vasculature, in order to allow for optimal choice of the graft in terms of diameter and compliance, thus providing more physiological mechanical environments, and enabling improved graft performance.
- The translation of research to clinics in collaboration with the radiology and cardiology units of Policlinico San Donato. A novel hybrid, semi-degradable hemodialysis vascular access suitable for in situ tissue engineering. In particular, with the aim of completing the necessary Design Dossier for future certification of Silkothane® graft as Class III medical device, BEL will carry out an extensive characterization of compliance-calibrated Silkothane® grafts, according to international standards. Mechanical tests will be performed in order to quantify the grafts’ circumferential and longitudinal strength, dynamical radial compliance, burst pressure, suture retention strength, strength after repeated puncture, kink radius, and water permeability, together with biocompatibility analyses (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, and bacterial reverse mutation).