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首页> 外文期刊>Journal of orthopaedics and traumatology: official journal of the Italian Society of Orthopaedics and Traumatology >Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial
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Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial

机译：快速吸收的载有抗生素的水凝胶涂层可减少内部骨合成后的术后感染：一项多中心随机对照试验

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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. 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. 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. 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. 2.
机译：感染是骨科植入物失败的主要原因之一。根据各种临床前研究，抗菌涂层可以防止细菌粘附和生物膜形成。本研究的目的是报告在为闭合性骨折进行内部骨合成的患者中，使用抗生素加载的快速吸收水凝胶涂层（防御性抗菌涂层，DAC®）以防止手术部位感染的首次临床试验。在这项多中心随机对照前瞻性研究中，计划将五个欧洲骨科中心的总共256名计划接受闭合闭合骨折的骨合成手术的患者随机分配接受抗生素加载的DAC或对照组（无涂层）。在固定的时间间隔进行术前和术后评估的实验室检查，伤口愈合，临床评分和X线检查。总共有253例患者，平均随访时间为18.1±4.5个月（范围12-30）。平均而言，两组之间的伤口愈合，临床评分，实验室检查和影像学检查结果无明显差异。在对照组中观察到六种手术部位感染（4.6％），而在治疗组中没有观察到（P <0.03）。没有观察到与DAC水凝胶产品有关的局部或全身性副作用，也没有发现对骨愈合的可检测干扰。使用可快速吸收的载有抗生素的水凝胶植入物涂层，可在闭合闭合骨折的内部骨合成后降低术后部位感染的发生率，而没有任何可检测到的不良事件或副作用。 2。

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