Clinical Trial: A Randomized Trial Comparing Matt and Antimicrobial Cellomed Laminates

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 tha
Sponsor: County Durham and Darlington NHS Foundation Trust

Current Primary Outcome: Percentage increase in bacteria total viable count [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: To compare the number of different types of specific organisms identified during the laboratory analysis. [ Time Frame: 24 hours ]

The secondary objective is to compare the number of different types of specific organisms identified in the two groups following 24 hours of clinical use.


Original Secondary Outcome: Same as current

Information By: County Durham and Darlington NHS Foundation Trust

Dates:
Date Received: November 22, 2010
Date Started: February 2011
Date Completion: March 2011
Last Updated: November 22, 2010
Last Verified: November 2010