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临床试验/NCT02351895
NCT02351895已完成不适用

Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use in a Single Intensive Care Unit

Eastern Virginia Medical School1 个研究点 分布在 1 个国家目标入组 1,302 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,302
试验地点
1
主要终点
Antibiotic usage in copper impregnated vs regular linen wards >48 hours after admission to ICU

研究概览

简要总结

This is a prospective Infection Control study comparing rates of antibiotic usage and infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens versus regular linens.

详细描述

One ward of the ICU had copper impregnated linen while the other had regular linen. This included sheets, pillowcases, towels and patient gowns. After the first 23 week period was completed, there was a 3 week washout period. After this, the wards were switched with the first using regular linen and the second using copper impregnated linen.

The investigators followed participants and documented any infections >48 hours after admission to the ICU. The number and days of antibiotics used for the infections were also documented. Using assigned study numbers, the investigators obtained demographic data: age, sex, co-morbid conditions, and admitting diagnosis. All participants were followed daily in the GICU and daily for 48 hours after transfer to the regular floor. Date of discharge will be obtained retrospectively. Infection control (IC) routinely obtains Methicillin Resistant Staphylococcus Aureus (MRSA) nasal swabs on all patients on admission to the GICU, once weekly while in GICU and then again on discharge from the GICU. They monitor the GICU patients for healthcare associated infections (HAI) that meet the National Healthcare Safety Network (NHSN) 146 definitions. The NHSN is a widely used HAI tracking system, and the infections documented included Ventilator associated pneumonia (VAP), Catheter related blood stream infections (CLABSI), catheter associate urinary tract infections (CAUTI) and Clostridium difficile associated diarrhea (CDAD). They also obtain information on decubitus ulcers (bed sores) that develop during hospital stay. Infection control also routinely monitors the isolation of multi-drug resistant bacteria, namely Vancomycin Resistant Enterococci (VRE), Extended Spectrum beta Lactamase producing organisms (ESBL) and Carbapenemase producing enterobacteriaceae (CRE) as well as Multi drug resistant (MDR ) Acinetobacter baumanii from cultures. This above information will be obtained from the IC nurses on a weekly basis by the investigators.

As most of the infections in the ICU do not meet strict NHSN criteria, the investigators defined an infection as: the physician diagnosing an infection, and then initiating antibiotics for the same.

Copper linen were implemented the same as regular linen. There was no difference in the nursing or physician staff on either side. No interventions were made other than existing hospital wide IC interventions

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients >18 years and <90 years who were admitted to the GICU during the study period

排除标准

  • Those that did not meet the age criteria as above.
  • Any patients with Menke's syndrome or Wilson's disease
  • Any patient with an allergy to copper or iodine
  • Any patient who wishes to opt out of participating

结局指标

主要结局

Antibiotic usage in copper impregnated vs regular linen wards >48 hours after admission to ICU

时间窗: Two study periods of 23 weeks each

To assess whether the use of copper impregnated linens was associated with decreased use of antibiotics

次要结局

  • Decrease in clinical infection(Two study periods of 23 weeks each)
  • Decrease in NHSN infection(Two study periods of 23 weeks each)

研究者

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

SShankaran

Assistant Professor, Internal Medicine, Division of Infectious Diseases

Eastern Virginia Medical School

研究点 (1)

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