A Randomized Trial Comparing Matt and Antimicrobial Cellomed Laminates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by County Durham and Darlington NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
County Durham and Darlington NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01245829
First received: November 22, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  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:


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).

  Show Detailed Description

  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 April 15, 2014