Effectiveness of Screening and Decolonization of S. aureus in Surgery Outpatients

描述（由申请方提供）：S.外科门诊患者中的金黄色葡萄球菌金黄色葡萄球菌（SA）卫生保健相关感染（HAI）导致显著的发病率和死亡率。SA导致15%的HAI和30%的手术部位感染（SSI）。每年有超过4000万美国人接受手术，其中1-10%将获得SSI。这种感染使住院时间和死亡风险增加一倍，并使美国的医疗保健费用每年增加50亿至100亿美元。我们需要有效的干预措施来预防由甲氧西林敏感（MSSA）或甲氧西林耐药（MRSA）菌株引起的SSI。SA的鼻携带者（25-30%的成年人）获得SA SSI的风险比非携带者高2-14倍。一种潜在的预防方法是对患者进行常规术前筛查，然后对已确定的SA携带者进行去殖民化。这项研究的长期目标是 是减少由SA引起的SSI的发生率，MSSA和MRSA菌株。这将有助于提高美国人医疗保健的安全性和有效性。实现这一目标需要我们首先解决以下关键知识差距：（i）哪些手术患者应在术前进行筛查;（ii）哪些身体部位应进行筛查以获得最佳SA检测;以及（iii）哪种去殖民化方法最适合门诊使用。R 03提案的近期目标和重点是进行确定术前SA携带率所需的研究（包括菌株类型和携带部位），以评价患者在家自行管理的SA去殖民化方案的实用性（依从性、成本）。拟开展一项随机临床试验（RCT），评估莫匹罗星鼻用软膏、氯吡格雷漱口液和氯吡格雷术前沐浴的疗效，患者在术前在家进行5天。该方案将与当前的护理标准进行比较，通常在手术前用消毒肥皂淋浴1-2次。简单地说，目的如下：目的1：确定一种新的去殖民化方案的有效性，与标准的护理相比，在外科门诊患者术前消除SA携带。我们假设，SA根除率将是2-3倍，在干预组相比，标准的护理arm. Aim 2：获得数据，告知样本量计算和成本估计的随机对照试验，以防止SSI，确定筛选要求，并评估治疗依从性。我们将：根据SA类型、MSSA、CA-MRSA和HA-MRSA确定术前SA携带者的比例和携带部位，确定对研究干预和标准治疗的依从性、不依从的原因，并收集成本数据以提供干预潜在成本效益的初步证据。目的3：确定SA携带的风险因素（人口统计学、医学）（MSSA和MRSA的总体和单独，按CA-和HA-MRSA划分）。收集研究对象SSI的初步数据。

DESCRIPTION (provided by applicant): Effectiveness of Screening and Decolonization of S. aureus in Surgery Outpatients Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such infections double the length of hospitalization and risk of dying, and increase U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA SSI. A potential prevention approach is routine pre-operative screening of patients, followed by decolonization of identified SA carriers. The long term goal of this research is to reduce the incidence of SSIs caused by SA, both MSSA and MRSA strains. This will help improve the safety and effectiveness of health care for Americans. Achievement of this goal requires that we first address the following critical knowledge gaps: (i) which surgical patients should be screened pre-operatively; (ii) which body site(s) should be screened for optimal SA detection, and (iii) which decolonization approach is optimal for outpatient use. The immediate goal, and the focus of this R03 proposal, is to conduct the research needed to determine pre-operative SA carriage rates (including by strain type and site of carriage), to evaluate the practicality (adherence, cost) of a SA decolonization protocol that is self-administered by patients at home. propose to conduct a randomized clinical trial (RCT) of the efficacy of nasal mupirocin ointment, CHG mouth rinse, and CHG pre-operative bathing, as performed by the patient at home for 5 days pre-operatively. This protocol will be compared with the current standard of care, usually 1-2 showers with an antiseptic soap before the procedure. Briefly, the aims are as follows: Aim 1: Determine the efficacy of a novel decolonization protocol, compared with standard of care, for eradicating SA carriage pre-operatively in surgery out-patients. We hypothesize that the SA eradication rate will be 2-3 times higher in the intervention arm compared with the standard of care arm. Aim 2: Obtain data to inform sample size calculations and cost estimates for a RCT to prevent SSIs, determine screening requirements, and assess treatment adherence. We will: determine the proportion of pre-operative patients who are SA carriers and the sites of carriage, by SA type, MSSA, CA-MRSA, and HA- MRSA, determine adherence to the study intervention and standard of care, reasons for non-compliance, and gather cost data to provide preliminary evidence of potential cost-effectiveness of the intervention. Aim 3: Identify risk factors (demographic, medical) for SA carriage (overall and separately for MSSA and MRSA, split by CA- and HA-MRSA). Gather preliminary data on SSIs in study subjects.