The general aim of the present research is to develop, validate and bring to the market a fast resorbable, disposable anti-biofilm and anti-bacterial coating of biomaterials, to prevent and treat implant-related infections in orthopaedics and traumatology.
With a share of 38%, orthopaedic and traumatology (O&T) are the worldwide leading market of implanted biomaterials, involving millions of new patients each year at an increasing trend.
Bacterial infections associated with implanted biomaterials represent the most devastating complication in O&T, involving millions of citizens worldwide. Considering an average incidence of 2%, more than 20,000 new peri-prosthetic infections are acquired every year in Europe, however, due to the chronic behavior and frequent relapses of the disease, one may estimate that there are hundreds of thousands European citizens with a chronic peri-prosthetic joint infection and hundreds of thousands more with chronic implant-related infections after osteosynthesis for the internal fixation of fractures or osteotomies.
[+] Read More
Figure 1: Biofilm remnants surrounding an explanted acetabular cup of an infected hip prosthesis (A - arrow) (courtesy of Prof. C.L. Romanò, Galeazzi Orthopaedic Institute, Milan, Italy).
Biofilm (red) and bacteria (green) as they appear at the confocal laser microscopy (B) (courtesy of Prof. L. Drago, Galeazzi Orthopaedic Institute, Milan, Italy).
I.D.A.C. is intended to defend the implanted biomaterial before bacteria replication and biofilm production take place, providing a local protection through high local concentrations of anti-biofilm and anti-bacterial compounds, without inducing any drug resistance, thanks to the fast and complete resorption of the coating within the first days after surgery.
Aim of the present research is to develop, validate and bring to the market a disposable coating of implanted biomaterial (Implant Disposable Antibacterial Coating, I.D.A.C.). The device, based on a novel, proprietary, resorbable hydrogel (Fig. 2), will act as a fast resorbable, local delivery carrier of anti-biofilm and anti-bacterial compounds.
Figure 2: The Implant Disposable Antibacterial Coating (I.D.A.C.), is based on a proprietary, resorbable hydrogel, developed in the laboratories of Novagenit S.r.l. (A); this collaborative project will test the ability of the hydrogel to be intra-operatively mixed with anti-biofilm and anti-bacterial compounds and applied to the surface of different biomaterials (B), to offer protection against bacteria colonization and biofilm formation.
The active drug (anti-biofilm and antibiotic agents) will be mixed at the time of the hydrogel application during surgery, allowing the correct choice for any given patient, reducing costs and regulatory requirements and improving storage life and versatility of use.
Through local delivery and complete, fast resorption, I.D.A.C. will represent a novel approach to early control biofilm formation, prevent bacterial colonization and treat established implant-related infections, without any risk of inducing new drug resistance and alter the environment.
Novelty, versatility, ease-of-use, efficacy, safety and reduced costs are the key-factors for the success of the present idea: aim of the present collaborative research project is to provide enough data to support them.
The project will demonstrate:
In particular, I.D.A.C. will be shown:
Local anti-biofilm and anti-bacterial delivery through a fast resorbable hydrogel coating may significantly change both prophylaxis and treatment strategies of implant-related surgical infections in O&T and set new standard of the surgical practice.
The device is intended to be firstly introduced for the use in O&T, the leading market of implanted medical devices; however, once established, the technology may be easily transferred to other potential markets, including maxillo-facial surgery, neurosurgery, plastic surgery, cardiovascular surgery, etc.