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dc.creatorMalizos K., Blauth M., Danita A., Capuano N., Mezzoprete R., Logoluso N., Drago L., Romanò C.L.en
dc.date.accessioned2023-01-31T08:56:18Z
dc.date.available2023-01-31T08:56:18Z
dc.date.issued2017
dc.identifier10.1007/s10195-017-0442-2
dc.identifier.issn15909921
dc.identifier.urihttp://hdl.handle.net/11615/76196
dc.description.abstractBackground: 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. © 2017, The Author(s).en
dc.language.isoenen
dc.sourceJournal of Orthopaedics and Traumatologyen
dc.source.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85011556520&doi=10.1007%2fs10195-017-0442-2&partnerID=40&md5=b07efe3a0f7a494980f3896760403d67
dc.subjectamikacinen
dc.subjectantibiotic agenten
dc.subjectC reactive proteinen
dc.subjectcefazolinen
dc.subjectgentamicinen
dc.subjectvancomycinen
dc.subjectantiinfective agenten
dc.subjectbiocompatible coated materialen
dc.subjectadulten
dc.subjectageden
dc.subjectArticleen
dc.subjectbone radiographyen
dc.subjectclinical assessmenten
dc.subjectcontrolled studyen
dc.subjectfemaleen
dc.subjectfollow upen
dc.subjectfractureen
dc.subjectfracture nonunionen
dc.subjectfracture reductionen
dc.subjecthumanen
dc.subjecthydrogelen
dc.subjectlaboratory testen
dc.subjectmajor clinical studyen
dc.subjectmaleen
dc.subjectmaterial coatingen
dc.subjectmulticenter studyen
dc.subjectosteosynthesisen
dc.subjectoutcome assessmenten
dc.subjectperioperative perioden
dc.subjectpostoperative perioden
dc.subjectpreoperative evaluationen
dc.subjectpriority journalen
dc.subjectprospective studyen
dc.subjectrandomized controlled trialen
dc.subjectscoring systemen
dc.subjectsurgical infectionen
dc.subjectwound dehiscenceen
dc.subjectwound healingen
dc.subjectclinical trialen
dc.subjectdevicesen
dc.subjectdrug combinationen
dc.subjectdrug effectsen
dc.subjectEuropeen
dc.subjecthydrogelen
dc.subjectincidenceen
dc.subjectmiddle ageden
dc.subjectosteosynthesisen
dc.subjectpharmacologyen
dc.subjectsurgical infectionen
dc.subjecttime factoren
dc.subjecttreatment outcomeen
dc.subjectvery elderlyen
dc.subjectyoung adulten
dc.subjectAdulten
dc.subjectAgeden
dc.subjectAged, 80 and overen
dc.subjectAnti-Bacterial Agentsen
dc.subjectCoated Materials, Biocompatibleen
dc.subjectDrug Combinationsen
dc.subjectEuropeen
dc.subjectFemaleen
dc.subjectFollow-Up Studiesen
dc.subjectFracture Fixation, Internalen
dc.subjectFractures, Closeden
dc.subjectHumansen
dc.subjectHydrogelsen
dc.subjectIncidenceen
dc.subjectMaleen
dc.subjectMiddle Ageden
dc.subjectProspective Studiesen
dc.subjectSurgical Wound Infectionen
dc.subjectTime Factorsen
dc.subjectTreatment Outcomeen
dc.subjectWound Healingen
dc.subjectYoung Adulten
dc.subjectSpringer-Verlag Italia s.r.l.en
dc.titleFast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trialen
dc.typejournalArticleen


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