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临床试验/NCT04900298
NCT04900298招募中不适用

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

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits

研究概览

简要总结

The investigators hypothesize that the use of a personal hand hygiene system (SafeHavenTM) by anesthesia providers in the adult operating room, combined with a novel infectious pathogen tracking system (OR PathTrac) will decrease participant exposure to pathologic bacteria in the adult operating room.

详细描述

This will be a prospective, single center, unmasked, controlled before and after study.

Intervention Arm: Use of SafeHaven hand hygiene system in the operating room

Control Arm: Standard of care hand hygiene

Operating Room Selection: Two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for detection of pathogenic bacteria. The operating room for investigation will be randomly selected through the following process:

  1. All the operating rooms with scheduled surgeries in the South Operating Rooms on a particular day will be entered into a random number generator (example: operating rooms 2, 3, 5, 7).
  2. The random generator will sort these operating rooms into a rank list (example: operating rooms 5, 3, 2, 7).
  3. The investigators will start at the top of this list and work down until the first operating room meeting all inclusion criteria is found (example: operating room 5 only has one surgery, operating room 3 has pediatric surgery, operating room 2 meets inclusion criteria)
  4. This process will be duplicated for each case-pair

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 18 years of age having surgery in an adult operating suite at the research center involving the following specialties: orthopedics/spine, orthopedics/total joint, gynecology/oncology, colorectal, open vascular, and open urological, general abdominal, acute care, cardiothoracic, and plastic/breast.

排除标准

  • Patients with a known infection at the time of surgery.
  • Prisoners
  • Pregnant Women
  • Patients lacking capacity to consent
  • Patients with an allergy to a component of hand hygiene solution, such as ethyl alcohol
  • Refusal of consent
  • Anesthesia Provider Inclusion Criteria:
  • Faculty physicians, resident physicians, or certified registered nurse anesthetists that provide care for adults having surgery at the research center.
  • Anesthesia Provider Exclusion Criteria:
  • Refusal of consent
  • Open sores of the hands
  • Known skin infection

结局指标

主要结局

Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits

时间窗: Perioperative Time, typically less than 12 hours

The following reservoirs will be cultured at case start (anesthesia machine adjustable pressure limiting valve, patient nare, patient axilla, patient groin, anesthesia provider dominant hand, primary assigned anesthesia assistant) and at case end (anesthesia machine adjustable pressure limiting valve, patient nare, patient axilla, patient groin, anesthesia provider dominant hand, primary assigned anesthesia assistant, and internal lumen of intravenous tubing stopcock) within the operating room suite using a sterile collection kit.

次要结局

  • Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software.(30 days following surgery)
  • Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events(30 days following surgery)

研究者

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

Brandon M Togioka

Principal Investigator

Oregon Health and Science University

研究点 (2)

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