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.
Defensive Antibacterial Coating, DAC®
