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临床试验/NCT03992209
NCT03992209已完成不适用

Reducing Intraoperative ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter Spp.) Transmission In the Pediatric Operating Room Via Use of a Personal Hand Hygiene System Optimized by OR PathTrac

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Transmission of pathologic bacteria in the operating room

研究概览

简要总结

Patients becoming infected during hospitalization occurs frequently and causes harm. It is important for healthcare facilities to take action to prevent these infections and their spread between patients. Despite the presumption of a "sterile" environment, one place where spread of infection is known to happen is in the operating room. This occurs as a result of frequent interaction among healthcare providers, the patient and the environment of the room. Hand washing is an important component of preventing the spread of infections. Scientific evidence has shown that making it easier for people to wash their hands can have two important impacts: (1) reduction of environmental bacterial contamination and (2) reduction in spread of bacterial pathogens. OR PathTrac is new technology that allows tracking of bacterial spread. While data exists about bacterial contamination and transmission in the adult operating room, there is very minimal data about this in the pediatric operating room. Primary aim: To use OR PathTrac to evaluate the effect of a personal hand washing device in reducing operating room exposure to bacterial pathogens in pediatric patients. We hypothesize that this hand washing system will decrease exposure to pathologic bacteria in the pediatric operating room. Secondary aim: To gain knowledge about baseline bacterial contamination and transmission in pediatric operating rooms. We will answer this question by comparing bacterial cultures taken from operating rooms whose personnel are trained to use the hand washing device to operating rooms who are not trained to use the device.

详细描述

I. Hypotheses: The investigators hypothesize that the use of a personal hand hygiene system by anesthesia providers in the OR, combined with a novel infectious pathogen tracking system will decrease patient exposure to pathologic bacteria in the pediatric operating room.

Primary aim: To use a novel pathogen tracking system (OR PathTrac) to evaluate the effect of a personal hand hygiene device in reducing operating room exposure to bacterial pathogens in pediatric patients.

Secondary aim: To gain knowledge about the baseline bacterial contamination and transmission patterns in pediatric operating rooms.

II. Background and Significance:

Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. These infections are becoming more difficult to treat due to antibiotic resistance. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria between patients. ESKAPE bacteria (Enterococcus, S. aureus , Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly problematic because they have a unique capacity to acquire resistance traits.8 Isolation of these organisms from intraoperative reservoirs has been associated with postoperative infection development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All intraoperative providers at Children's Hospital Colorado will be eligible to participate
  • Pediatric patients age 1-18 years old presenting to the main operating room at Children's Hospital Colorado who will require general anesthesia with placement of a peripheral intravenous catheter.

排除标准

  • Adult patients, age greater than 18 years old
  • Patients without an intravenous catheter

结局指标

主要结局

Transmission of pathologic bacteria in the operating room

时间窗: 6 months

We will use a novel bioinformatics system to track pathogen transmission in the operating room between anesthesia providers, the anesthesia environment and patients.

次要结局

  • Baseline pathogen contamination among pediatric surgical patients(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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