Bacteria-proof resorbable implant coating for orthopaedics Orthopaedic implantations, i.e. arthroplasties and trauma devices, are associated with surgical site infections and thus biofilm formation. EU-funded researchers worked on developing implantable, biocompatible, resorbable coating mixed with antibacterial agents for infection prevention. Industrial Technologies Health © stockdevil, Thinkstock A rapidly resorbable biocompatible hydrogel formulation derived hyaluronic acid biopolymer has recently been patented. The multinational I.D.A.C. (Implant disposable antibacterial coating (I.D.A.C.): a novel approach to implant-related infections in orthopaedics and trauma surgery) project has developed and validated a resorbable, anti-bacterial coating to prevent implant-related infections during orthopaedic and trauma surgery. The hydrogel has been designed so that the antibiotics can be intra-operatively loaded. This prevents bacterial colonisation and biofilm formation as well as minimises the risk of drug-resistant bacterial strains emerging. Project members assessed the safety, costs, efficacy, ease-of-use, shelf-life and sterilisation of the hydrogel. Two clinical trials in hip / knee arthroplasties and in traumatology were successfully completed during the last part of the project. Researchers confirmed that the quality, shelf-life and safety of the I.D.A.C. products are adequate and validated sterilisation through beta irradiation technique. In vitro tests were conducted to assess the efficacy of the products preloaded with antibacterial agents. The antibacterial agents tested included vancomycin, gentamycin, tobramycin, amikacin and N-acetylcystein (NAC). Good antibiotic and anti-biofilm activity was observed against pathogens such as Staphylococcus aureus and Staphylococcus epidermidis without any cytotoxicity. The I.D.A.C. prototypes showed promising results in terms of adhesion to implants in tests conducted on human cadaveric femur or rabbit tibia as well as in in vivo studies on rabbits. Besides biocompatibility, product preparation and application procedures were also successfully designed and tested. Clinical trials (randomised, single blind, controlled, multicentre, international) referred to traumatology and joint arthroplasty, the patients' enrolment and the planned 12-month follow up were all concluded. The results showed a statistically significant difference between the I.D.A.C. product group and the control group. Efficacy: no infection was reported in the group treated with the product while 7.5 % of the control group developed an infection. (p=0.0023). Regarding safety, no adverse event related to the product occurred. project members established a central database and data collection procedures. Dissemination activities included the project website, brochures, participation in meetings and publications. the I.D.A.C. product is expected to be in high demand in the healthcare sector where implant-related infections pose a huge socio-economic burden. This coating technology could also be adapted to other market segments such as plastic surgery, neurosurgery, dental surgery and oncological orthopaedic Keywords Implant coating, orthopaedics, biocompatible hydrogel, I.D.A.C., anti-bacterial coating
