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临床试验/NCT03972826
NCT03972826终止不适用

Epicenters for the Prevention of Healthcare Associated Infections (HAIs) -- Volume of Contamination and Nosocomial Infection Control: Specific Aim II.1

University of Iowa0 个研究点目标入组 27 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
主要终点
Percent of participants whose hands were colonized after doffing gloves

研究概览

简要总结

The investigators will assess whether applying Provodine, an FDA-approved hand hygiene product with a long duration of anti-microbial action, to healthcare workers' hands protects against self-contamination during the removal of personal protective equipment (gloves, gowns, etc).

详细描述

We will perform a two-armed pilot test among 40 front-line healthcare workers (nurses, doctors, respiratory therapists, etc) at the University of Iowa Hospitals and Clinics. Participants will serve as their own controls. First, participants will perform hand hygiene with alcohol-based hand rub as they normally would in clinical practice then don PPE. We, the research team, will contaminate participating healthcare workers' (HCW) PPE with either bacteriophage MS2 (twenty participants) or S. marcescens ATCC 14756 (twenty participants). MS2 preparation and propagation and S. marcescens culture suspensions will each be performed as previously described. The MS2 bacteriophage will be suspended in 0.01 M phosphate-buffered saline and each PPE site will be contaminated with 10^5 plaque-forming units (PFU) of MS2 in 5 drops of 5 μL each. Aliquots of 3 mL of S. marcescens broth suspension (yielding bacterial titers of ~1 X 10^9 CFU/ml) will be applied to each PPE site. Participants will then doff PPE using the Centers for Disease Control's (CDC) recommended protocol. We will sample their hands using the bag broth method. A research assistant will monitor participants as they wash their hands with soap and water then rinse their hands with 70% ethanol. Participants will then apply ProvodineTM to their hands and put on (don) fresh PPE. We will repeat the contamination, doffing, and sampling procedure. For MS2 recovery, we will assay the eluent using the most probable number (MPN) enrichment infectivity assay. For S. marcescens recovery, we will dilute the eluent, plate it, incubate the plates, and count the colonies as described.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Subjects must be UIHC healthcare workers (doctors, nurses, etc.)

排除标准

  • Known skin sensitivity to povidone iodine or Provodine (TM)

结局指标

主要结局

Percent of participants whose hands were colonized after doffing gloves

时间窗: 30 minutes

The percent of participants whose hands were contaminated with either S marcescens or the phage MS2 after doffing gloves when participants did hand hygiene before the trial with an alcohol-based hand rub compared with that when participants had done hand hygiene before the trial with Provodine

Colony-forming units (CFU) or Plaque forming units (PFU) on participants' hands

时间窗: 30 minutes

The number of S. marcescens CFU or MS2 plaque forming units (PFU) on participants hands when they did hand hygiene before the trial with an alcohol-based hand rub compared with when participants had done hand hygiene before the trial with Provodine

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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