University of Minnesota Medical School, Department of Medicine, Division of Infectious Diseases, Minneapolis, Minnesota.
Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, Minnesota.
Infect Control Hosp Epidemiol. 2018 Sep;39(9):1049-1057. doi: 10.1017/ice.2018.151. Epub 2018 Jul 24.
To determine the efficacy in eradicating Staphylococcus aureus (SA) carriage of a 5-day preoperative decolonization bundle compared to 2 disinfectant soap showers, with both regimens self-administered at home.
Open label, single-center, randomized clinical trial.
Ambulatory orthopedic, urologic, neurologic, colorectal, cardiovascular, and general surgery clinics at a tertiary-care referral center in the United States.ParticipantsPatients at the University of Minnesota Medical Center planning to have elective surgery and not on antibiotics.
Consenting participants were screened for SA colonization using nasal, throat, axillary, and perianal swab cultures. Carriers of SA were randomized, stratified by methicillin resistance status, to a decolonization bundle group (5 days of nasal mupirocin, chlorhexidine gluconate [CHG] bathing, and CHG mouthwash) or control group (2 preoperative showers with antiseptic soap). Colonization status was reassessed preoperatively. The primary endpoint was absence of SA at all 4 screened body sites.
Of 427 participants screened between August 31, 2011, and August 9, 2016, 127 participants (29.7%) were SA carriers. Of these, 121 were randomized and 110 were eligible for efficacy analysis (57 decolonization bundle group, 53 control group). Overall, 90% of evaluable participants had methicillin-susceptible SA strains. Eradication of SA at all body sites was achieved for 41 of 57 participants (71.9%) in the decolonization bundle group and for 13 of 53 participants (24.5%) in the control group, a difference of 47.4% (95% confidence interval [CI], 29.1%-65.7%; P<.0001).
An outpatient preoperative antiseptic decolonization bundle aimed at 4 body sites was significantly more effective in eradicating SA than the usual disinfectant showers (ie, the control).Trial RegistrationClinicalTrials.gov identifier: NCT02182115.
比较 5 天术前去定植套餐与 2 次抗菌皂淋浴，两者均由患者在家中自行使用，以确定前者在消除金黄色葡萄球菌（SA）定植方面的疗效。
开放标签、单中心、随机临床试验。
美国一家三级转诊中心的门诊骨科、泌尿科、神经科、结直肠科、心血管科和普外科诊所。
明尼苏达大学医学中心计划接受择期手术且未使用抗生素的患者。
使用鼻、咽、腋窝和肛周拭子培养对符合条件的参与者进行 SA 定植筛查。SA 定植者随机分为去定植套餐组（5 天鼻腔莫匹罗星、葡萄糖酸氯己定[CHG]沐浴和 CHG 漱口水）或对照组（术前 2 次用抗菌皂淋浴），按耐甲氧西林状态分层。术前再次评估定植状态。主要终点为所有 4 个筛查部位均无 SA。
2011 年 8 月 31 日至 2016 年 8 月 9 日筛查了 427 名参与者，其中 127 名（29.7%）为 SA 定植者。其中，121 名被随机分配，110 名符合疗效分析条件（去定植套餐组 57 名，对照组 53 名）。总体而言，90%可评估参与者的 SA 菌株对甲氧西林敏感。去定植套餐组 57 名参与者中 41 名（71.9%）和对照组 53 名参与者中 13 名（24.5%）所有部位的 SA 均被清除，差异为 47.4%（95%置信区间[CI]，29.1%-65.7%；P<.0001）。
针对 4 个部位的门诊术前抗菌去定植套餐在消除 SA 方面明显优于常规消毒剂淋浴（即对照组）。
ClinicalTrials.gov 标识符：NCT02182115。
