Objective 1 : To develop and test the ability of the patented hydrogel to deliver known and new antibiofilm compounds and antibacterial and antimicotic agents; in order to do this, adequately high levels of various antibiofilm and antibacterial agents should be achieved locally in vitro. Shelf-life and sterilization procedures will also be investigated as a part of this objective.
Objective 2 : To develop and test the ability of the technology under study to prevent early bacterial colonization and biofilm formation on implanted biomaterials in vivo. In order to achieve this goal, I.D.A.C. will be tested in animal model, against different nosocomial bacterial strains, alone and in combination with various antibiofilm and antibacterial agents and on different biomaterials commonly used in O&T. Furthermore, non-fouling properties of the hydrogel and the effect of associations between antibiotics and antibiofilm agents will be tested.
Objective 3 : To test the ability of I.D.A.C. to disrupt biofilms once established and decrease infection rates in contaminated or infected implants, from different microorganisms. This objective will be achieved through microbiological tests both in vitro and in vivo, with various antibiofilm and antibacterial agents and with different biomaterials.
Objective 4 : To test the complete hydrogel resorption within a pre-defined, controlled period of time, avoiding the risk of delayed unwanted side effects or interference with osteointegration of the implant. The achievement of this goal will be a part of the in vivo animal experimental setting.
Objective 5 : To develop and test a simple tool for intra-operative mixing of the hydrogel with the selected antibiofilm and antibacterial compounds and to test in vivo the best procedure to achieve a complete coating of the implant, both at the bone and soft tissue interface.
Objective 6 : To assess safety, efficacy and ease-of-use in the clinical setting. To this aim three clinical trials are planned to be performed in the second part of this collaborative research project, according to the indications that will emerge from the in vitro and in vivo tests.
Data from all research trials (both in vitro and in vivo) will be collected and electronically forwarded to the central database. All data will be processed and a statistical analysis will be performed.
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