A Randomized Trial Comparing Matt and Antimicrobial Cellomed Laminates - Full Text View

Purpose

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.

Condition	Intervention
Cross Infection Infection Control	Other: Swabbing of observation chart

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Bacterial Contamination of Critical Care Observation Charts: a Randomized Trial Comparing Matt and Antimicrobial Cellomed Laminates.

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Infection Control

U.S. FDA Resources

Further study details as provided by County Durham and Darlington NHS Foundation Trust:

Primary Outcome Measures:

Percentage increase in bacteria total viable count [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

To compare the number of different types of specific organisms identified during the laboratory analysis. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	200
Study Start Date:	February 2011
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Matt A standard non antimicrobial laminated chart which will form the control group (group 1).	Other: Swabbing of observation chart The observation charts to be studied will be stored on the DMH critical care unit and all existing non-laminated white charts removed for the duration of the study period. The observation charts will thereafter be used in the normal way as defined by nursing practice; blue charts from patient admission (irrespective of time) and white charts for each 24 hour period thereafter commencing at 8 am. On placement and after 24 hours of use, a standardised section of the patient observation area will be swabbed by the data collection researcher. The standardised area is defined as the section of the chart that is most comprehensively completed during the patient episode and is therefore most likely to become contaminated through contact. Use of white charts only is required in order to standardise the length of time each chart is in place between the two points of swabbing (white charts present at 8 am have been in use for exactly 24 hours).
Experimental: Cellomed Observation charts coated in a laminate with antimicrobial properties (Cellomed) will form group 2.	Other: Swabbing of observation chart The observation charts to be studied will be stored on the DMH critical care unit and all existing non-laminated white charts removed for the duration of the study period. The observation charts will thereafter be used in the normal way as defined by nursing practice; blue charts from patient admission (irrespective of time) and white charts for each 24 hour period thereafter commencing at 8 am. On placement and after 24 hours of use, a standardised section of the patient observation area will be swabbed by the data collection researcher. The standardised area is defined as the section of the chart that is most comprehensively completed during the patient episode and is therefore most likely to become contaminated through contact. Use of white charts only is required in order to standardise the length of time each chart is in place between the two points of swabbing (white charts present at 8 am have been in use for exactly 24 hours).

Arms

Assigned Interventions

Placebo Comparator: Matt

A standard non antimicrobial laminated chart which will form the control group (group 1).

Other: Swabbing of observation chart

The observation charts to be studied will be stored on the DMH critical care unit and all existing non-laminated white charts removed for the duration of the study period. The observation charts will thereafter be used in the normal way as defined by nursing practice; blue charts from patient admission (irrespective of time) and white charts for each 24 hour period thereafter commencing at 8 am. On placement and after 24 hours of use, a standardised section of the patient observation area will be swabbed by the data collection researcher. The standardised area is defined as the section of the chart that is most comprehensively completed during the patient episode and is therefore most likely to become contaminated through contact. Use of white charts only is required in order to standardise the length of time each chart is in place between the two points of swabbing (white charts present at 8 am have been in use for exactly 24 hours).

Experimental: Cellomed

Observation charts coated in a laminate with antimicrobial properties (Cellomed) will form group 2.

Other: Swabbing of observation chart

The observation charts to be studied will be stored on the DMH critical care unit and all existing non-laminated white charts removed for the duration of the study period. The observation charts will thereafter be used in the normal way as defined by nursing practice; blue charts from patient admission (irrespective of time) and white charts for each 24 hour period thereafter commencing at 8 am. On placement and after 24 hours of use, a standardised section of the patient observation area will be swabbed by the data collection researcher. The standardised area is defined as the section of the chart that is most comprehensively completed during the patient episode and is therefore most likely to become contaminated through contact. Use of white charts only is required in order to standardise the length of time each chart is in place between the two points of swabbing (white charts present at 8 am have been in use for exactly 24 hours).

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Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245829

Contacts

Contact: Richard C Hixson, FRCA	01325 743327	Richard.Hixson@cddft.nhs.uk
Contact: Richard Geary, FRCA	0132 743327	Richard.Geary@cddft.nhs.uk

Locations

United Kingdom
Darlington Memorial Hospital	Not yet recruiting
Darlington, County Durham, United Kingdom, DL3 6HX

Sponsors and Collaborators

County Durham and Darlington NHS Foundation Trust

Investigators

Principal Investigator:

Richard C Hixson, FRCA

County Durham and Darlington Acute Hospitals NHS Foundation Trust

More Information

No publications provided

Responsible Party:	Dr Richard Hixson, County Durham and Darlington NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01245829 History of Changes
Other Study ID Numbers:	Cellomed001
Study First Received:	November 22, 2010
Last Updated:	November 22, 2010
Health Authority:	National Health Service ENGLAND:

Keywords provided by County Durham and Darlington NHS Foundation Trust:

Cross Infection
Nosocomial Infection
Healthcare Acquired Infection
Hospital Paperwork

Observation Charts
Critical Care
Contamination

Additional relevant MeSH terms:

Cross Infection
Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013