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用于重症监护病房表面清洁的有机硅烷:一项交叉集群随机对照试验方案

Organosilane for surface cleaning in intensive care units: protocol for a cluster randomized controlled trial with crossover.

作者信息

Nassar Junior Antonio Paulo, Silva Claudia Vallone, Righi Camila Gosenheimer, Bezerra Isabella Lott, Carvalho Andrea de, Patrocínio Ana Cristina Lagoeiro, Souza Eduvirgens Maria Couto de, Rodrigues Mirian Batista, Santos Tiago Mendonça Dos, Oliveira Luiz Felipe Valter de, Christoff Ana Paula, Teixeira Bianca Luise, Besen Bruno Adler Maccagnan Pinheiro, Veiga Viviane Cordeiro, Cavalcanti Alexandre Biasi, Tomazini Bruno Martins, Pereira Adriano José

机构信息

Hospital Israelita Albert Einstein - São Paulo (SP), Brazil.

BiomeHub - Florianópolis (SC), Brazil.

出版信息

Crit Care Sci. 2025 Jul 11;37:e20250319. doi: 10.62675/2965-2774.20250319. eCollection 2025.

DOI:10.62675/2965-2774.20250319
PMID:40667968
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12266816/
Abstract

OBJECTIVE

To assess whether surface disinfection with organosilane in the intensive care unit reduces the occurrence of healthcare-associated infections.

METHODS

This multicenter, controlled, cluster-randomized trial includes 14 intensive care units in Brazil from November 2023 to December 2024. The local hygiene team of the included intensive care units will disinfect bed surfaces with organosilane or with usual care for 6 months, followed by a sequential crossover of another 6 months. The primary outcome is the incidence of healthcare-associated infections, specifically ventilator-associated pneumonia, central-line-associated bloodstream infections, and catheter-associated urinary tract infections. The secondary endpoints are the contamination of the environment by multidrug-resistant microorganisms (i.e., oxacillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, carbapenem-resistant Enterobacter, Pseudomonas, and Acinetobacter), the incidence of specific infections (i.e., ventilator-associated pneumonia, central-line associated bloodstream infection, and catheter-associated urinary tract infection) and the cost of the patient's intensive care unit stay. We will enroll all adult patients admitted after the study begins in each participant's intensive care unit.

ETHICS AND DISSEMINATION

The institutional review board of the coordinator center and each enrolled center approved the study protocol. We will disseminate the results in peer-reviewed journals and at scientific meetings, regardless of the study's outcome.

摘要

目的

评估重症监护病房中使用有机硅烷进行表面消毒是否能降低医疗相关感染的发生率。

方法

这项多中心、对照、整群随机试验于2023年11月至2024年12月在巴西的14个重症监护病房进行。纳入的重症监护病房的当地卫生团队将使用有机硅烷或常规护理对病床表面进行6个月的消毒,随后进行为期6个月的顺序交叉。主要结局是医疗相关感染的发生率,特别是呼吸机相关性肺炎、中心静脉导管相关血流感染和导尿管相关尿路感染。次要终点是耐多药微生物对环境的污染(即耐苯唑西林金黄色葡萄球菌、耐万古霉素粪肠球菌、耐碳青霉烯肠杆菌、假单胞菌和不动杆菌)、特定感染的发生率(即呼吸机相关性肺炎、中心静脉导管相关血流感染和导尿管相关尿路感染)以及患者在重症监护病房的住院费用。我们将纳入每个参与的重症监护病房在研究开始后收治的所有成年患者。

伦理与传播

协调中心和每个参与中心的机构审查委员会批准了研究方案。无论研究结果如何,我们都将在同行评审期刊和科学会议上公布结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2b03/12266816/32fb5a049a9e/2965-2774-ccsci-37-e20250319-gf01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2b03/12266816/32fb5a049a9e/2965-2774-ccsci-37-e20250319-gf01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2b03/12266816/32fb5a049a9e/2965-2774-ccsci-37-e20250319-gf01.jpg

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Crit Care Sci. 2024 Sep 2;36:e20240150en. doi: 10.62675/2965-2774.20240150-en. eCollection 2024.
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16S rRNA amplicon sequencing and antimicrobial resistance profile of intensive care units environment in 41 Brazilian hospitals.41 家巴西医院重症监护病房环境的 16S rRNA 扩增子测序和抗菌药物耐药谱。
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Patient-level cost analysis of intensive care unit-acquired infections: a prospective cohort study.
重症监护病房获得性感染的患者层面成本分析:一项前瞻性队列研究。
J Hosp Infect. 2025 May;159:106-114. doi: 10.1016/j.jhin.2024.07.002. Epub 2024 Jul 18.
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Patient-level costs of central line-associated bloodstream infections caused by multidrug-resistant microorganisms in a public intensive care unit in Brazil: a retrospective cohort study.巴西一家公立重症监护病房中由多重耐药微生物引起的中心静脉导管相关血流感染的患者层面成本:一项回顾性队列研究。
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IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units.IMPACTO-MR:巴西全国性平台研究,评估重症监护病房的感染和多重耐药情况。
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Evidence Map and Systematic Review of Disinfection Efficacy on Environmental Surfaces in Healthcare Facilities.医疗机构环境表面消毒效果的证据图和系统评价。
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