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

外科门诊患者金黄色葡萄球菌筛查和去定植的有效性

• 批准号: 8678530
• 负责人: Susan Elizabeth Kline
• 金额: $ 5万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2016-06-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8678530
• 关键词: Effectiveness; Screening; Decolonization; S.; aureus

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.

描述(由申请人提供)：外科门诊金黄色葡萄球菌(SA)医疗相关感染(HAI)的筛查和非定殖化的有效性导致显著的发病率和死亡率。SA导致了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%的人将获得SSI。这种感染使住院时间和死亡风险增加了一倍，并使美国的医疗保健成本每年增加50-100亿美元。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。金黄色葡萄球菌鼻部携带者(25%-30%的成年人)感染金黄色葡萄球菌的风险是非金黄色葡萄球菌携带者的2-14倍。一种可能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携带者进行非殖民化处理。这项研究的长期目标是 是为了减少金黄色葡萄球菌引起的SSIS的发生率，包括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。实现这一目标要求我们首先解决以下关键知识差距：(I)哪些外科患者应该在手术前进行筛查；(Ii)应该对哪个身体部位(S)进行筛查以获得最佳的SA检测；以及(Iii)哪种非殖民化方法最适合门诊使用。R03提案的直接目标和重点是进行必要的研究，以确定术前SA携带率(包括菌株类型和携带部位)，评估由患者在家中自我管理的SA非殖民化方案的实用性(依从性、成本)。建议进行一项随机临床试验(RCT)，观察患者术前在家中使用莫匹罗星软膏、CHG含漱液和CHG术前沐浴的疗效。这一方案将与目前的护理标准进行比较，通常是在手术前1-2次用杀菌肥皂淋浴。简而言之，目标如下：目标1：确定一项新的非殖民化议定书与护理标准相比，在外科门诊患者术前根除金黄色葡萄球菌携带者方面的有效性。我们假设，与标准护理组相比，干预组的金黄色葡萄球菌根治率将提高2-3倍。目标2：获得数据，为随机对照试验的样本量计算和成本估计提供信息，以预防SSI，确定筛查要求，并评估治疗依从性。我们将：按SA类型、MSSA、CA-MRSA和HA-MRSA确定术前金黄色葡萄球菌携带者的比例和携带部位，确定遵守研究干预和护理标准、不遵守的原因，并收集成本数据，以提供干预措施潜在成本效益的初步证据。目标3：确定SA携带者的危险因素(人口、医学)(MSSA和MRSA总体和单独，按CA-和HA-MRSA划分)。收集研究对象中SSI的初步数据。