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临床试验/NCT01245829
NCT01245829Unknown不适用

Bacterial Contamination of Critical Care Observation Charts: a Randomized Trial Comparing Matt and Antimicrobial Cellomed Laminates.

County Durham and Darlington NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Percentage increase in bacteria total viable count

研究概览

简要总结

Sepsis contributes to nearly 20% of all hospital deaths and is the leading cause of death on non-coronary intensive care units. Contamination of the patient environment is common with organisms such as MRSA, VRE and C.difficile remaining viable for days or weeks on a variety materials and surfaces. Up to 90% of patient notes and charts on critical care may be contaminated with potential pathogens including MRSA and it has been shown that healthcare workers may contaminate hospital paperwork with organisms originating from patients. Cellomed is a triclosan based laminate which has been shown to possess antimicrobial activity against MRSA, E.Coli, Enterococcus, Stenotrophomonas and Klebsiella. The study presented for consideration aims to compare levels of contamination between critical care observation charts coated with either a 'standard' matt or antimicrobial Cellomed laminate. It is proposed that paperwork laminated with Cellomed may exhibit reduced levels of contamination and decrease the potential for cross infection on critical care and potentially other areas of the hospital in which clinical paperwork is handled.

详细描述

Although hand hygiene remains an important intervention in reducing the incidence of nosocomial infection, poor compliance may limit its impact especially in critical care units when clinical demands on staff are high. Although focused programmes to improve compliance have been shown to produce good results this may not be sustained in the longer-term. Hand hygiene only reduces and does not completely eliminate hand contamination and therefore transmission of hand microbes to the near-patient environment including paperwork will inevitably occur. It is recommended that healthcare professionals undertake hand hygiene after interacting with the patient environment even if contact with the patient has not taken place. In practice this may not occur as the potential for the environment to act as a reservoir may not be realised by healthcare workers.

Doctors reviewing physiological trends on critical care observation charts often move between bed-spaces without touching patients or undertaking hand hygiene. Since doctors exhibit the lowest level of compliance with hand hygiene programmes, it is likely to be difficult to persuade them to undertake additional manoeuvres before and after handing paperwork as has been recommended. Effective cleaning and disinfection of the near-patient environment should occur concurrently to hand hygiene programmes in order to reduce transmission. Critical care observation charts in Darlington Memorial Hospital are paper-based, located in near-patient hand-touch zones and are therefore prone to contamination. It is proposed that treated paperwork may exhibit reduced levels of contamination; decreasing the potential for cross infection resulting from an area of the near-patient hand-touch environment that has received little attention in the past.

Recently published research (2009) has reported that up to 90% of critical care observation charts may be contaminated with potential or actual pathogens. It is on critical care where nosocomial infections potentially have the most devastating effect. Cellomed is a triclosan based laminate that has been available since 2008 through Celloglas, a UK company specialising in decorative and other print finishes. Celloglas claim the laminate possesses anti-microbial activity citing three reports from Ciba laboratories (Switzerland), Scientific Services (UK) and Manchester University (UK). All tests have shown activity against MRSA and E.Coli with the most recent test reporting additional activity against Enterococcus, Stenotrophomonas and Klebsiella when compared to control. To date there have been no studies of Cellomed carried out in the clinical environment. Cellomed can be applied to any hospital paperwork through a lamination process. It is proposed that 'treated' paperwork will exhibit reduced levels of contamination when used in the clinical environment compared with standard patient documentation.

This will be a prospective, randomised study comparing percentage increases in bacterial total viable count on critical care observation charts coated with one of two different materials; standard matt or Cellomed antibacterial laminate.

Two-hundred of our standard white critical care observation charts will be provided to Celloglas (Leeds, UK). 100 of these will be laminated with standard matt (group 1) and 100 with anti-microbial Cellomed (group 2). The two types of charts will be separately packaged by Celloglas, labelled and delivered to lead investigator at Darlington Memorial Hospital. The packages will be opened on a sterile work surface and the lead investigator will number the charts in a random order determined by an Excel spreadsheet. Randomisation will be restricted to ensure 100 charts remain in each group. The lead investigator will record which chart type is assigned to each number for analysis purposes. The charts will be used by the critical care nursing staff in the assigned order to ensure the random sequence is maintained.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • All 200 of the specifically prepared, laminated white observation charts present on critical care will be included in the study.

排除标准

  • White critical care charts in place at the time of a patient discharges will be excluded from analysis. This is due to the fact they would not have been in place for the full 24 hours and would not be available to have the 2nd swab sample taken. Blue observation charts are excluded since they are used for a variable period of time between patient admission and 8 am.

结局指标

主要结局

Percentage increase in bacteria total viable count

时间窗: 24 hours

Due to the claimed continuous expression of antimicrobial activity, there is the potential for baseline total viable counts to be lower in the Cellomed group on receipt from the lamination factory. In addition, it cannot be assumed that the baseline contamination will be identical for charts between or within the two groups. It is therefore proposed to define the primary outcome measure as the percentage increase in total viable count from pre- 24 hour levels as measured before clinical use on critical care.

次要结局

  • To compare the number of different types of specific organisms identified during the laboratory analysis.(24 hours)

研究者

申办方类型
Other Gov

研究点 (2)

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