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临床试验/NCT03886337
NCT03886337撤回不适用

Evaluation of the Impact of Germicidal Light on Intraoperative S. Aureus Exposure

University of Iowa2 个研究点 分布在 1 个国家开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit.

研究概览

简要总结

Visible light at 405nm has been shown to be germicidal. The hypothesis is that use of this light (Indigo-Clean Lights) in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.

详细描述

Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light at 405nm has been shown to be germicidal. Investigators plan to install ambient, germicidal lighting (Indigo-Clean Lights) that uses this wavelength in 4 operating rooms. Patients will undergo surgery according to usual practice. Investigators will conduct a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without the germicidal lights. Patients will be matched by procedure then case duration then American Society of Anesthesiologists (ASA) physical status health classification. These patients will undergo infection surveillance. Infection surveillance will involve use of National Healthcare Safety Network (NHSN) checklists applied to patients who are positive for one or more of the initial screening criteria (elevated white blood cell count, fever (>38.4 degrees Celsius), office note documentation of infection, positive culture (sputum, blood, urine, wound, other body fluid), or anti-infective order within the 90 postoperative day period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult, at least 18 years old
  • Adult patients undergoing orthopedic, cardiothoracic, gyn/onc, and neuro surgery and general anesthesia according to usual care with peripheral and/or central venous access.

排除标准

  • Pediatric (<18 years old),
  • Incarcerated, and/or
  • Pregnant patients
  • Undergoing surgery and/or without peripheral or central venous access.
  • Undergoing surgery outside of the classifications above

结局指标

主要结局

S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit.

时间窗: Approximately 103 work days

OR reservoirs will be surveyed for S. aureus isolation and epidemiologically-relatedness assessed

次要结局

  • 90-day postoperative SSIs, superficial and/or deep.(1.6 years)
  • 90-day HAIs (combined incidence of SSIs, respiratory, blood stream, catheter-associated urinary tract, and C. Difficile infections).(1.6 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randy Loftus

Associate Professor of Anesthesia and Critical Care Medicine

University of Iowa

研究点 (2)

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