{"title":"Pre-surgical Nasal Decolonization of <i>Staphylococcus aureus:</i> A Health Technology Assessment.","authors":"","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong><i>Staphylococcus aureus (S. aureus)</i> is the most common cause of surgical site infections, and the nose is the most common site for <i>S. aureus</i> colonization. Pre-surgical (in the days prior to surgery) nasal decolonization of <i>S. aureus</i> may reduce the bacterial load and prevent the organisms from being transferred to the surgical site, thus reducing the risk of surgical site infection. We conducted a health technology assessment of nasal decolonization of <i>S. aureus</i> (including methicillin-susceptible and methicillin-resistant strains) with or without topical antiseptic body wash to prevent surgical site infection in patients undergoing scheduled surgery, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nasal decolonization of <i>S. aureus</i>, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and selected and reported results from one review that was recent, of high quality, and relevant to our research question. We complemented the chosen systematic review with a literature search to identify randomized controlled trials published since the systematic review was published in 2019. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review and the Cochrane risk-of-bias tool for randomized controlled trials to assess the risk of bias of each included primary study. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted both cost-effectiveness and cost-utility analyses using a decision-tree model with a 1-year time horizon from the perspective of Ontario's Ministry of Health. We also analyzed the budget impact of publicly funding nasal decolonization of <i>S. aureus</i> in pre-surgical patients in Ontario. To contextualize the potential value of nasal decolonization, we spoke with people who had recently undergone surgery, some of whom had received nasal decolonization, and one family member of a person who had recently had surgery. We also engaged participants through an online survey.</p><p><strong>Results: </strong>We included one systematic review and three randomized controlled trials in the clinical evidence review. In universal decolonization, compared with placebo or no intervention, nasal mupirocin alone may result in little to no difference in the incidence of overall and <i>S. aureus</i>-related surgical site infections in pre-surgical patients undergoing orthopaedic, cardiothoracic, general, oncologic, gynaecologic, neurologic, or abdominal digestive surgeries, regardless of <i>S. aureus</i> carrier status (GRADE: Moderate to Very low). Compared with placebo, nasal mupirocin alone may result in little to no difference in the incidence of overall and <i>S. aureus</i>-related surgical site infections in pre-surgical patients who are <i>S. aureus</i> carriers undergoing cardiothoracic, vascular, orthopaedic, gastrointestinal, general, oncologic, gynaecologic, or neurologic surgery (GRADE: Moderate to Very low). In targeted decolonization, compared with placebo, nasal mupirocin combined with chlorhexidine body wash lowers the incidence of <i>S. aureus</i>-related surgical site infection (risk ratio: 0.32 [95% confidence interval: 0.16-0.62]) in pre-surgical patients who are <i>S. aureus</i> carriers undergoing cardiothoracic, vascular, orthopaedic, gastrointestinal, or general surgery (GRADE: High). Compared with no intervention, nasal mupirocin combined with chlorhexidine body wash in pre-surgical patients who are not <i>S. aureus</i> carriers undergoing orthopaedic surgery may have little to no effect on overall surgical site infection, but the evidence is very uncertain (GRADE: Very low). Most included studies did not separate methicillin-susceptible and methicillin-resistant strains of <i>S. aureus</i>. No significant antimicrobial resistance was identified in the evidence reviewed; however, the existing literature was not adequately powered and did not have sufficient follow-up time to evaluate antimicrobial resistance.Our economic evaluation found that universal nasal decolonization using mupirocin combined with chlorhexidine body wash is less costly and more effective than both targeted and no nasal decolonization. Compared with no nasal decolonization treatment, universal and targeted nasal decolonization using mupirocin combined with chlorhexidine body wash would prevent 32 and 22 <i>S. aureus</i>-related surgical site infections, respectively, per 10,000 patients. Universal nasal decolonization would lead to cost savings, whereas targeted nasal decolonization would increase the overall cost for the health care system since patients must first be screened for <i>S. aureus</i> carrier status before receiving nasal decolonization with mupirocin. The annual budget impact of publicly funding universal nasal decolonization in Ontario over the next 5 years ranges from a savings of $2.98 million in year 1 to a savings of $15.09 million in year 5. The annual budget impact of publicly funding targeted nasal decolonization ranges from an additional cost of $0.08 million in year 1 to an additional cost of $0.39 million in year 5.Our interview and survey respondents felt strongly about the value of preventing surgical site infections, and most favoured a universal approach.</p><p><strong>Conclusions: </strong>Based on the best evidence available, decolonization of <i>S. aureus</i> using nasal mupirocin combined with chlorhexidine body wash prior to cardiothoracic, vascular, orthopaedic, gastrointestinal, or general surgery lowers the incidence of surgical site infection caused by <i>S. aureus</i> in patients who are <i>S. aureus</i> carriers (including methicillin-susceptible and methicillin-resistant strains) (i.e., targeted decolonization). However, nasal mupirocin alone may result in little to no difference in overall surgical site infections and <i>S. aureus</i>-related surgical site infections in pre-surgical patients prior to orthopaedic, cardiothoracic, general, oncologic, gynaecologic, neurologic, or abdominal digestive surgeries, regardless of their <i>S. aureus</i> carrier status (i.e., universal decolonization). No significant antimicrobial resistance was identified in the evidence reviewed.Compared with no nasal decolonization treatment, universal nasal decolonization with mupirocin combined with chlorhexidine body wash may reduce <i>S. aureus</i>-related surgical site infections and lead to cost savings. Targeted nasal decolonization with mupirocin combined with chlorhexidine body wash may also reduce <i>S. aureus</i>-related surgical site infections but increase the overall cost of treatment for the health care system. We estimate that publicly funding universal nasal decolonization using mupirocin combined with chlorhexidine body wash would result in a total cost savings of $45.08 million over the next 5 years, whereas publicly funding targeted nasal decolonization using mupirocin combined with chlorhexidine body wash would incur an additional cost of $1.17 million over the next 5 years.People undergoing surgery value treatments aimed at preventing surgical site infections.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"22 4","pages":"1-165"},"PeriodicalIF":0.0000,"publicationDate":"2022-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9470215/pdf/ohtas-22-4.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ontario Health Technology Assessment Series","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Staphylococcus aureus (S. aureus) is the most common cause of surgical site infections, and the nose is the most common site for S. aureus colonization. Pre-surgical (in the days prior to surgery) nasal decolonization of S. aureus may reduce the bacterial load and prevent the organisms from being transferred to the surgical site, thus reducing the risk of surgical site infection. We conducted a health technology assessment of nasal decolonization of S. aureus (including methicillin-susceptible and methicillin-resistant strains) with or without topical antiseptic body wash to prevent surgical site infection in patients undergoing scheduled surgery, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nasal decolonization of S. aureus, and patient preferences and values.
Methods: We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and selected and reported results from one review that was recent, of high quality, and relevant to our research question. We complemented the chosen systematic review with a literature search to identify randomized controlled trials published since the systematic review was published in 2019. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review and the Cochrane risk-of-bias tool for randomized controlled trials to assess the risk of bias of each included primary study. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted both cost-effectiveness and cost-utility analyses using a decision-tree model with a 1-year time horizon from the perspective of Ontario's Ministry of Health. We also analyzed the budget impact of publicly funding nasal decolonization of S. aureus in pre-surgical patients in Ontario. To contextualize the potential value of nasal decolonization, we spoke with people who had recently undergone surgery, some of whom had received nasal decolonization, and one family member of a person who had recently had surgery. We also engaged participants through an online survey.
Results: We included one systematic review and three randomized controlled trials in the clinical evidence review. In universal decolonization, compared with placebo or no intervention, nasal mupirocin alone may result in little to no difference in the incidence of overall and S. aureus-related surgical site infections in pre-surgical patients undergoing orthopaedic, cardiothoracic, general, oncologic, gynaecologic, neurologic, or abdominal digestive surgeries, regardless of S. aureus carrier status (GRADE: Moderate to Very low). Compared with placebo, nasal mupirocin alone may result in little to no difference in the incidence of overall and S. aureus-related surgical site infections in pre-surgical patients who are S. aureus carriers undergoing cardiothoracic, vascular, orthopaedic, gastrointestinal, general, oncologic, gynaecologic, or neurologic surgery (GRADE: Moderate to Very low). In targeted decolonization, compared with placebo, nasal mupirocin combined with chlorhexidine body wash lowers the incidence of S. aureus-related surgical site infection (risk ratio: 0.32 [95% confidence interval: 0.16-0.62]) in pre-surgical patients who are S. aureus carriers undergoing cardiothoracic, vascular, orthopaedic, gastrointestinal, or general surgery (GRADE: High). Compared with no intervention, nasal mupirocin combined with chlorhexidine body wash in pre-surgical patients who are not S. aureus carriers undergoing orthopaedic surgery may have little to no effect on overall surgical site infection, but the evidence is very uncertain (GRADE: Very low). Most included studies did not separate methicillin-susceptible and methicillin-resistant strains of S. aureus. No significant antimicrobial resistance was identified in the evidence reviewed; however, the existing literature was not adequately powered and did not have sufficient follow-up time to evaluate antimicrobial resistance.Our economic evaluation found that universal nasal decolonization using mupirocin combined with chlorhexidine body wash is less costly and more effective than both targeted and no nasal decolonization. Compared with no nasal decolonization treatment, universal and targeted nasal decolonization using mupirocin combined with chlorhexidine body wash would prevent 32 and 22 S. aureus-related surgical site infections, respectively, per 10,000 patients. Universal nasal decolonization would lead to cost savings, whereas targeted nasal decolonization would increase the overall cost for the health care system since patients must first be screened for S. aureus carrier status before receiving nasal decolonization with mupirocin. The annual budget impact of publicly funding universal nasal decolonization in Ontario over the next 5 years ranges from a savings of $2.98 million in year 1 to a savings of $15.09 million in year 5. The annual budget impact of publicly funding targeted nasal decolonization ranges from an additional cost of $0.08 million in year 1 to an additional cost of $0.39 million in year 5.Our interview and survey respondents felt strongly about the value of preventing surgical site infections, and most favoured a universal approach.
Conclusions: Based on the best evidence available, decolonization of S. aureus using nasal mupirocin combined with chlorhexidine body wash prior to cardiothoracic, vascular, orthopaedic, gastrointestinal, or general surgery lowers the incidence of surgical site infection caused by S. aureus in patients who are S. aureus carriers (including methicillin-susceptible and methicillin-resistant strains) (i.e., targeted decolonization). However, nasal mupirocin alone may result in little to no difference in overall surgical site infections and S. aureus-related surgical site infections in pre-surgical patients prior to orthopaedic, cardiothoracic, general, oncologic, gynaecologic, neurologic, or abdominal digestive surgeries, regardless of their S. aureus carrier status (i.e., universal decolonization). No significant antimicrobial resistance was identified in the evidence reviewed.Compared with no nasal decolonization treatment, universal nasal decolonization with mupirocin combined with chlorhexidine body wash may reduce S. aureus-related surgical site infections and lead to cost savings. Targeted nasal decolonization with mupirocin combined with chlorhexidine body wash may also reduce S. aureus-related surgical site infections but increase the overall cost of treatment for the health care system. We estimate that publicly funding universal nasal decolonization using mupirocin combined with chlorhexidine body wash would result in a total cost savings of $45.08 million over the next 5 years, whereas publicly funding targeted nasal decolonization using mupirocin combined with chlorhexidine body wash would incur an additional cost of $1.17 million over the next 5 years.People undergoing surgery value treatments aimed at preventing surgical site infections.
背景:金黄色葡萄球菌(S. aureus)是外科手术部位感染最常见的原因,而鼻子是金黄色葡萄球菌最常见的定植部位。术前(手术前几天)对金黄色葡萄球菌进行鼻腔去定殖可以减少细菌负荷,防止细菌转移到手术部位,从而降低手术部位感染的风险。我们对接受预定手术的患者使用或不使用局部抗菌沐浴液预防手术部位感染的金黄色葡萄球菌(包括甲氧西林敏感菌株和甲氧西林耐药菌株)鼻腔去菌落进行了一项卫生技术评估,其中包括对有效性、安全性、成本效益、公共资助金黄色葡萄球菌鼻腔去菌落的预算影响以及患者的偏好和价值观的评估。方法:我们对临床证据进行了系统的文献检索,以检索系统综述,并从一篇最近的、高质量的、与我们的研究问题相关的综述中选择并报告了结果。我们通过文献检索来补充所选的系统评价,以确定自该系统评价于2019年发表以来发表的随机对照试验。我们使用系统评价的偏倚风险(ROBIS)工具评估每个纳入的系统评价的偏倚风险,并使用Cochrane随机对照试验的偏倚风险工具评估每个纳入的主要研究的偏倚风险。我们根据建议分级评估、发展和评价(GRADE)工作组标准评估了证据体的质量。我们进行了系统的经济文献检索,并从安大略省卫生部的角度使用决策树模型进行了1年时间范围的成本效益和成本效用分析。我们还分析了安大略省术前患者中金黄色葡萄球菌鼻腔去菌落的公共资助的预算影响。为了了解鼻部去殖民化的潜在价值,我们采访了最近接受过手术的人,其中一些人接受了鼻部去殖民化,还有一位最近接受过手术的人的家庭成员。我们还通过在线调查吸引了参与者。结果:临床证据综述纳入1项系统综述和3项随机对照试验。在普遍去菌落中,与安慰剂或无干预相比,在接受骨科、心胸外科、普通外科、肿瘤科、妇科、神经系统或腹部消化手术的术前患者中,单独使用鼻用莫匹罗星可能导致总体和金黄色葡萄球菌相关手术部位感染的发生率几乎没有差异,而不管金黄色葡萄球菌携带者是否存在(GRADE:中度至极低)。与安慰剂相比,在接受心胸外科、血管外科、骨科、胃肠外科、普通外科、肿瘤、妇科或神经外科手术的金黄色葡萄球菌携带者的术前患者中,单独使用鼻用莫匹罗星可能导致总体和金黄色葡萄球菌相关手术部位感染的发生率几乎没有差异(GRADE:中度至极低)。在靶向去菌落方面,与安慰剂相比,鼻用莫匹罗星联合氯己定沐浴露降低了术前接受心胸外科、血管外科、骨科、胃肠道或普通外科的金黄色葡萄球菌携带者的金黄色葡萄球菌相关手术部位感染的发生率(风险比:0.32[95%可信区间:0.16-0.62])(GRADE:高)。与不干预相比,非金黄色葡萄球菌携带者接受骨科手术的术前患者鼻用莫匹罗星联合氯己定沐浴露对手术部位整体感染的影响可能很小或没有影响,但证据非常不确定(GRADE: very low)。大多数纳入的研究没有分离甲氧西林敏感和耐甲氧西林金黄色葡萄球菌菌株。在审查的证据中未发现显著的抗菌素耐药性;然而,现有的文献没有足够的动力,也没有足够的随访时间来评估抗菌素耐药性。我们的经济评估发现,使用莫匹罗星联合氯己定沐浴露进行普遍的鼻腔去殖民化比有针对性的和没有鼻腔去殖民化更便宜,更有效。与不进行鼻腔去菌落治疗相比,普遍和有针对性地使用莫匹罗星联合氯己定沐浴露进行鼻腔去菌落治疗,每10000例患者分别可预防32例和22例金黄色葡萄球菌相关手术部位感染。普遍的鼻腔去菌落治疗可以节省成本,而有针对性的鼻腔去菌落治疗则会增加医疗保健系统的总体成本,因为患者在接受莫匹罗星鼻腔去菌落治疗之前必须首先对金黄色葡萄球菌携带者进行筛查。 公共资助在安大略省普及鼻部非殖民化在未来5年的年度预算影响从第一年节省298万美元到第五年节省1509万美元不等。以鼻非殖民化为目标的公共资助的年度预算影响范围从第一年的额外费用8万美元到第五年的额外费用39万美元不等。我们的访谈和调查受访者强烈认为预防手术部位感染的价值,最赞成的是一种通用的方法。结论:根据现有的最佳证据,在心胸、血管、骨科、胃肠或普外科手术前使用鼻用莫匹罗星联合氯己定沐浴露对金黄色葡萄球菌进行去菌落,可降低金黄色葡萄球菌携带者(包括甲氧西林敏感菌株和甲氧西林耐药菌株)引起的手术部位感染的发生率(即靶向去菌落)。然而,在骨科、心胸外科、普通外科、肿瘤科、妇科、神经系统或腹部消化外科手术前的术前患者,无论其金黄色葡萄球菌携带状态(即普遍去菌落)如何,单独使用鼻用莫匹罗星可能导致总体手术部位感染和金黄色葡萄球菌相关手术部位感染的差异很小或没有差异。在审查的证据中未发现明显的抗菌素耐药性。与不进行鼻腔去菌落治疗相比,普遍使用莫匹罗星联合氯己定沐浴露进行鼻腔去菌落治疗可减少金黄色葡萄球菌相关手术部位感染,节约成本。用莫匹罗星联合氯己定沐浴露进行针对性的鼻去菌落也可能减少金黄色葡萄球菌相关的手术部位感染,但增加了卫生保健系统的总体治疗成本。我们估计,公共资助使用莫匹罗星联合氯己定沐浴露的普遍鼻去殖民化将在未来5年内节省4508万美元的总成本,而公共资助使用莫匹罗星联合氯己定沐浴露的目标鼻去殖民化将在未来5年内产生117万美元的额外成本。接受手术的人重视旨在预防手术部位感染的治疗。