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General Orthopaedics

IS AN ANTIBIOTIC-LOADED HYDROGEL COATING ABLE TO REDUCE EARLY POST-SURGICAL INFECTION AFTER INTERNAL OSTEOSYNTHESIS?

European Bone and Joint Infection Society (EBJIS) meeting (1–3 September 2016).



Abstract

Aim

Aim of this study is to present the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating*, in patients undergoing internal osteosynthesis for closed fractures.

Method

In this prospective, multi-centre, randomized, controlled, prospective study, a total of 260 patients were randomly assigned, in five European orthopaedic centres, 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

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 (4.6%) 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.

Conclusions

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


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  • *

    Defensive Antibacterial Coating, DACĀ®