J Bone Jt Infect 2016; 1:34-41. doi:10.7150/jbji.15986

Research Paper

Does an Antibiotic-Loaded Hydrogel Coating Reduce Early Post-Surgical Infection After Joint Arthroplasty?

Carlo Luca Romanò1✉, Kostantinos Malizos2, Nicola Capuano3, Riccardo Mezzoprete4, Michele D'Arienzo5, Catherine Van Der Straeten6, 7, Sara Scarponi1, Lorenzo Drago8, 9

1. Department of Reconstructive Surgery of Osteo-articular Infections C.R.I.O. Unit, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
2. Orthopaedic Surgery & Trauma, Medical School, University of Thessaly, Larissa, Greece.
3. Department of Orthopaedics, San Luca Hospital - Vallo della Lucania, Italy.
4. Department of Orthopaedics, San Camillo de Lellis Hospital - Rieti, Italy.
5. Orthopaedic Surgery & Trauma, University Clinic, Palermo, Italy.
6. Department of Orthopaedics, Medical University Ghent, Belgium.
7. MSK Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.
8. Clinical Chemistry and Microbiology Laboratory, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
9. Laboratory of Medical Technical Sciences, Department of Biochemical Sciences for Health, University of Milano, Italy.

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Romanò CL, Malizos K, Capuano N, Mezzoprete R, D'Arienzo M, Van Der Straeten C, Scarponi S, Drago L. Does an Antibiotic-Loaded Hydrogel Coating Reduce Early Post-Surgical Infection After Joint Arthroplasty?. J Bone Jt Infect 2016; 1:34-41. doi:10.7150/jbji.15986. Available from http://www.jbji.net/v01p0034.htm

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Background: Infection remains among the main reasons for joint prosthesis failure. Preclinical reports have suggested that antibacterial coatings of implants may prevent bacterial adhesion and biofilm formation. This study presents the results of the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) in patients undergoing hip or knee prosthesis.

Methods: In this multicenter, randomized prospective study, a total of 380 patients, scheduled to undergo primary (n=270) or revision (n=110) total hip (N=298) or knee (N=82) joint replacement with a cementless or a hybrid implant, were randomly assigned, in six European orthopedic centers, to receive an implant either with the antibiotic-loaded DAC coating (treatment group) or without coating (control group). Pre- and postoperative assessment of clinical scores, wound healing, laboratory tests, and x-ray exams were performed at fixed time intervals.

Results: Overall, 373 patients were available at a mean follow-up of 14.5 ± 5.5 months (range 6 to 24). On average, wound healing, laboratory and radiographic findings showed no significant difference between the two groups. Eleven early surgical site infections were observed in the control group and only one in the treatment group (6% vs. 0.6%; p=0.003). No local or systemic side effects related to the DAC hydrogel coating were observed, and no detectable interference with implant osteointegration was noted.

Conclusions: The use of a fast-resorbable, antibiotic-loaded hydrogel implant coating can reduce the rate of early surgical site infections, without any detectable adverse events or side effects after hip or knee joint replacement with a cementless or hybrid implant.

Keywords: joint prosthesis, infection