Institute of Hygiene and Environmental Medicine, Charité-Universitätsmedizin Berlin, Hindenburgdamm 27, 12203, Berlin, Germany.
National Reference Center for Surveillance of Nosocomial Infections, Hindenburgdamm 27, 12203, Berlin, Germany.
Antimicrob Resist Infect Control. 2020 Nov 30;9(1):188. doi: 10.1186/s13756-020-00852-0.
Surgical site infections (SSI) are rare but severe complications after total joint arthroplasty (TJA). Decolonization measures prior to elective orthopedic surgeries have shown to reduce the risk of SSI with Staphylococcus aureus (S. aureus).
To determine the efficacy of universal decolonization with Polyhexanide on SSI rates with a focus on Staphylococcus aureus in patients with TJA.
Patients scheduled for elective hip or knee TJA in 5 participating certified orthopedic centers were included between 2015 and 2018 into this before and after study. Data on patients, surgeries and infections were prospectively collected. CDC-criteria were used to define and categorize Infections within 90 days after surgery. From January 2017 on, patients received decolonization sets containing Polyhexanide. Patients performed a 5 day decolonization regimen starting 4 days prior to surgery which included wipes, nasal decontamination and oral solution.
Thirteen thousand, three hundred fifteen patients received TJA. During intervention 4437 decolonization sets were distributed among 7175 patients. Overall SSI rates increased from 0.68 /100 surgeries to 0.91/ 100 surgeries after implementation of the intervention (IRR 1.32; 95% CI 0.90-1.96). Time series analysis identified an increasing trend of SSI prior to the intervention. After implementation overall SSI rates plateaued. Regression analysis revealed surgery during intervention period to be an independent risk factor for developing a SSI (OR 1.34; 95%CI 1.18-1.53). Initial SSI rates due to S. aureus were 0.24/100 surgeries and decreased to 0.14/100 surgeries (IRR 0.57; 95% CI 0.25-1.22) after introduction of decolonization. Regression analysis revealed surgery during intervention period to be an independent protective factor for developing a SSI with S. aureus (OR 0.57, 95% CI: 0.33-0.99). Overall deep S. aureus SSI decreased significantly from 0.22/100 surgeries to 0.00/100 surgeries in patients adherent to protocol (IRR 0.00, 95% CI 0.00-.85).
Universal decolonization with Polyhexanide did not reduce overall surgical site infections, but was effective in reducing Staphylococcus aureus - surgical site infections following elective joint arthroplasty. Polyhexanide could extend the list of alternatives to already established decolonization strategies.
The trial was registered at the German Registry for clinical studies www.drks.de ( DRKS00011505 ).
手术部位感染（SSI）是全关节置换术后罕见但严重的并发症。在择期骨科手术前进行去定植措施已显示出可降低金黄色葡萄球菌（S. aureus）所致 SSI 的风险。
确定聚六亚甲基胍（Polyhexanide）对全关节置换术患者 SSI 发生率（重点关注金黄色葡萄球菌）的疗效。
本研究为前瞻性的病例对照研究，纳入了 2015 年至 2018 年间 5 家参与认证的骨科中心计划接受择期髋关节或膝关节全关节置换术的患者。前瞻性收集患者、手术和感染数据。美国疾病控制与预防中心（CDC）标准用于定义和分类术后 90 天内的感染。自 2017 年 1 月起，患者接受含有聚六亚甲基胍的去定植套装。患者在手术前 4 天开始进行为期 5 天的去定植方案，包括擦拭、鼻腔去污染和口腔溶液。
共有 13315 名患者接受了全关节置换术。干预期间共发放了 4437 套去定植套装，共有 7175 名患者使用。干预实施后，SSI 总发生率从 0.68/100 例手术上升至 0.91/100 例手术（IRR 1.32；95%CI 0.90-1.96）。时间序列分析发现，在干预前 SSI 发生率呈上升趋势。实施干预后，SSI 总发生率趋于平稳。回归分析显示，干预期间的手术是发生 SSI 的独立危险因素（OR 1.34；95%CI 1.18-1.53）。金黄色葡萄球菌引起的初始 SSI 发生率为 0.24/100 例手术，在去定植后降至 0.14/100 例手术（IRR 0.57；95%CI 0.25-1.22）。回归分析显示，干预期间的手术是金黄色葡萄球菌所致 SSI 的独立保护因素（OR 0.57，95%CI：0.33-0.99）。总体而言，金黄色葡萄球菌深部 SSI 显著下降，从 0.22/100 例手术降至接受方案治疗的患者的 0.00/100 例手术（IRR 0.00，95%CI 0.00-0.85）。
聚六亚甲基胍的全身去定植并未降低总体手术部位感染率，但可有效降低择期关节置换术后金黄色葡萄球菌所致的手术部位感染率。聚六亚甲基胍可以扩大已建立的去定植策略的替代方案清单。
该试验在德国临床研究注册中心（www.drks.de）注册（DRKS00011505）。
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