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J Orthop Traumatol. 2017 Jun;18(2):159-169. doi: 10.1007/s10195-017-0442-2. Epub 2017 Feb 2.

Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial.

Author information

1
Orthopaedic Surgery and Trauma, Medical School, University of Thessaly, Larissa, Greece.
2
Department for Trauma Surgery, Medical University, Innsbruck, Austria.
3
Department for Orthopaedics, San Luca Hospital, Vallo Della Lucania, Italy.
4
Department for Orthopaedics, San Camillo de Lellis Hospital, Rieti, Italy.
5
Department of Reconstructive Surgery of Osteo-articular Infections CRIO Unit, IRCCS Galeazzi Orthopaedic Institute, Via R. Galeazzi 4, 20161, Milan, Italy.
6
Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy.
7
Laboratory of Medical Technical Sciences, Department of Biochemical Sciences for Health, University of Milano, Milan, Italy.
8
Department of Reconstructive Surgery of Osteo-articular Infections CRIO Unit, IRCCS Galeazzi Orthopaedic Institute, Via R. Galeazzi 4, 20161, Milan, Italy. carlo.romano@grupposandonato.it.

Abstract

BACKGROUND:

Infection is one of the main reasons for failure of orthopedic implants. Antibacterial coatings may prevent bacterial adhesion and biofilm formation, according to various preclinical studies. The aim of the present study is to report the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) to prevent surgical site infection, in patients undergoing internal osteosynthesis for closed fractures.

MATERIALS AND METHODS:

In this multicenter randomized controlled prospective study, a total of 256 patients in five European orthopedic centers who were scheduled to receive osteosynthesis for a closed fracture, were randomly assigned to receive antibiotic-loaded DAC or to a control group (without coating). Pre- and postoperative assessment of laboratory tests, wound healing, clinical scores and X-rays were performed at fixed time intervals.

RESULTS:

Overall, 253 patients were available with a mean follow-up of 18.1 ± 4.5 months (range 12-30). On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two groups. Six surgical site infections (4.6%) were observed in the control group compared to none in the treated group (P < 0.03). No local or systemic side-effects related to the DAC hydrogel product 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 post-surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side-effects.

LEVEL OF EVIDENCE:

2.

KEYWORDS:

Coating; DAC; Hydrogel; Infection; Osteosynthesis; Prevention

PMID:
28155060
PMCID:
PMC5429256
DOI:
10.1007/s10195-017-0442-2
[Indexed for MEDLINE]
Free PMC Article

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