A Randomized Trial Comparing Matt and Antimicrobial Cellomed Laminates

NCT01245829 | Unknown

• 1 other identifier: Cellomed001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cross Infection; Infection Control

Keywords

Cross Infection; Nosocomial Infection; Healthcare Acquired Infection; Hospital Paperwork; Observation Charts; Critical Care; Contamination

Outcome Measures

Primary Outcomes (1)

• Percentage increase in bacteria total viable count

  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.

  24 hours

Secondary Outcomes (1)

• To compare the number of different types of specific organisms identified during the laboratory analysis.

  24 hours

Study Arms (2)

Matt

PLACEBO COMPARATOR

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

Other: Swabbing of observation chart

Cellomed

EXPERIMENTAL

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

Other: Swabbing of observation chart

Interventions

Swabbing of observation chart OTHER

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).

Cellomed; Matt

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• County Durham and Darlington NHS Foundation Trust: lead

Study Sites (1)

Darlington Memorial Hospital

Darlington, County Durham, DL3 6HX, United Kingdom

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard C Hixson, FRCA

  County Durham and Darlington Acute Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard C Hixson, FRCA

CONTACT

01325 743327; Richard.Hixson@cddft.nhs.uk

Richard Geary, FRCA

CONTACT

0132 743327; Richard.Geary@cddft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 23, 2010

Record last verified: 2010-11

Locations

GB (1)