I.D.A.C.

Implant Disposable Antibacterial Coating (I.D.A.C.): a Novel Approach to Implant-Related Infections in Orthopaedics and Trauma Surgery

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 Obiettivo del progetto (Objective)

'With a share of 38%, orthopaedic and traumatology (O&T) are the worldwide leading markets of implanted biomaterials, involving millions of new patients each year at an increasing trend. Infection related to implanted medical devices is directly related to bacterial capability to establish multilayered, highly structured biofilms on artificial surfaces. Bacterial infections due to implanted biomaterials represent the most devastating complication in O&T, involving millions of European citizens. 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, would act as a fast resorbable local delivery carrier of antibiofilm and antibacterial compounds. The active drug (antibiofilm and antibiotic agents) will be mixed at the time of the hydrogel application, allowing the correct choice for any given patient, reducing regulatory requirements, improving storage life and versatility. In particular, I.D.A.C. will be tested as a resorbable carrier of drugs (e.g.: N-acetylcisteine and its derivatives, serratia peptidase and other peptides, etc.) already known from our studies for having excellent antibiofilm properties, while others are able to by-pass the intact biofilm barrier and kill the underlying bacteria, when locally administered. The final purpose of the present research is to set a novel approach to early control of biofilm formation,to prevent bacterial colonization of implanted material and to treat established implant-related infections and chronic wounds, without any risk of inducing new drug resistance and alter the environment. The research will be conducted under the aegis of the European Bone and Joint Infection Society and the European Hip Society, through a network of upper standard European research and clinical centers and experienced SMEs from eight Countries around Europe.'

Introduzione (Teaser)

Implanting biomaterials such as replacement joints carry the risk of contracting infections from biofilm formation. EU-funded researchers are working on developing implantable , biocompatible, resorbable coating mixed with antibacterial agents.

Descrizione progetto (Article)

A rapidly resorbable biocompatible hydrogel formulation derived from polymers like hyaluronic acid has recently been patented. The multinational http://www.i-dac.eu (IDAC) project is developing and validating this resorbable, anti-bacterial coating for the prevention of the implant-related infections in orthopaedics and trauma surgery.

The hydrogel has been designed so the antibiotics can be intra-operatively loaded. This will prevent bacterial colonization and biofilm formation as well as minimise the risk of drug-resistant bacterial strains emerging. Other aspects assessed include safety, costs, efficacy, ease-of-use, shelf-life and sterilisation of the hydrogel. Two clinical trials in hip / knee arthroplasties and in traumatology are being planned for the latter part of this project period.

Researchers confirmed that the quality, shelf-life and safety of the IDAC product is adequate and validated sterilisation through beta irradiation technique. In vitro tests were conducted to assess the efficacy of IDAC products preloaded with antibacterial agents. The antibacterial agents tested included vancomycin, gentamycin, tobramycin, amikacyin or N-acetyl-cystein (NAC). Good antibiotic and anti-biofilm activity was noted against pathogens such as Staphylococcus aureus and Staphylococcus epidermidis without any cytotoxicity.

The IDAC prototypes showed promising results in terms of adhesion to implants in tests conducted on human cadaveric femur or rabbit tibia. In vivo animal study results are forthcoming. Besides biocompatibility, product preparation and application procedures were also successfully designed and tested resulting in an application for CE marking. For the clinical trials, researchers have prepared the final protocols, case report forms and informed consent forms that are required for submission to relevant ethical committees.

For smooth data collection and processing, a central database and data collection procedures were developed. Dissemination activities to date include the project website, brochure and e-brochure design as well as participation in events (the First International Meeting held on December 2013 in Milan) and publications.

The orthopaedic and traumatology sector accounts for 38 % of the global market segment for implanted biomaterials. The IDAC 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 and chronic wound management.