gms | German Medical Science

Objectives: Infection is among the first reasons for failure of orthopedic implants. Various antibacterial coatings have been proposed or are under investigation, in order to prevent bacterial adhesion and biofilm formation and thus avoiding implant-related infections; however, very few of them are currently available in the clinical setting. Previous studies showed the in vitro and in vivo efficacy and safety of a fast resorbable hyaluronic and polylactic acid based hydrogel (DAC^®, Novagenit Srl, Mezzolombardo, TN), loaded with antibiotics or antibiofilm agents. Aim of this study is to report the results of the first prospective clinical trial in trauma patients using an antibiotic-loaded DAC hydrogel coating of implants for internal osteosynthesis.

Methods: In this prospective, multi-center, randomized, controlled, prospective study, a total of 256 patients were randomly assigned, in five European orthopedic centers, to receive the antibiotic-loaded DAC coating or to a control group, without coating. Pre- and post-operative assessment of laboratory tests, wound healing, clinical scores and x-rays were performed at fixed time intervals.

Results and Conclusion: 253 patients were available at follow-up. On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two-groups. Six early surgical site infections (4.7%) were observed in the control group compared to none in the treated group (p = 0.02). No local or systemic side effects related to DAC hydrogel coating were observed and no detectable interference with bone healing was noted.

The use of a fast-resorbable, antibiotic-loaded hydrogel implant coating provides a significant reduced rate of early surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side effects.