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


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.


METHODS
2.
Orthopaedic Surgery and Trauma, Medical School, University of Thessaly, Larissa, Greece.
Kostantinos
K
Malizos
Department for Trauma Surgery, Medical University, Innsbruck, Austria.
Michael
M
Blauth
Department for Trauma Surgery, Medical University, Innsbruck, Austria.
Adrian
A
Danita
Department for Orthopaedics, San Luca Hospital, Vallo Della Lucania, Italy.
Nicola
N
Capuano
Department for Orthopaedics, San Camillo de Lellis Hospital, Rieti, Italy.
Riccardo
R
Mezzoprete
Department of Reconstructive Surgery of Osteo-articular Infections CRIO Unit, IRCCS Galeazzi Orthopaedic Institute, Via R. Galeazzi 4, 20161, Milan, Italy.
Nicola
N
Logoluso
Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy.|Laboratory of Medical Technical Sciences, Department of Biochemical Sciences for Health, University of Milano, Milan, Italy.
Lorenzo
L
Drago
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.
Carlo Luca
CL
Romanò
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000494:pharmacology*; D020099:Coated Materials, Biocompatible / Q000494:pharmacology*; D004338:Drug Combinations; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal / Q000295:instrumentation*; D005596:Fractures, Closed / Q000601:surgery*; D006801:Humans; D020100:Hydrogels / Q000494:pharmacology*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*; D055815:Young Adult
D000900:Anti-Bacterial Agents; D020099:Coated Materials, Biocompatible; D004338:Drug Combinations; D020100:Hydrogels
Coating; DAC; Hydrogel; Infection; Osteosynthesis; Prevention