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ISRCTN
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ISRCTN65190967
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of tea tree oil (5%) body wash versus standard body wash to prevent colonisation with methicillin-resistant Staphylococcus aureus in critically ill adults
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Scientific title
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Acronym
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N/A
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Serial number at source
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EAT/3460/06
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Study hypothesis
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Methicillin-Resistant Staphylococcus Aureus (MRSA) colonisation among critically ill patients is reduced by daily washing with 5% Tea Tree Oil (TTO) body wash in comparison with standard body wash (Johnson's pH 5.5).
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Ethics approval
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1. Approved by the School of Nursing and Midwifery Research Ethics Committee at Queen's University Belfast on the 16th April 2007 (ref: 03 2007)
2. Approved by the Office for Research Ethics Committees Northern Ireland on the 3rd September 2007 (ref: 07/NIR03/71)
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Study design
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A single centre phase II/III prospective open-label randomised controlled clinical trial
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Countries of recruitment
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Northern Ireland
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Disease/condition/study domain
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Critical illness; Methicillin-Resistant Staphylococcus Aureus (MRSA)
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Participants - inclusion criteria
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Patients admitted to the Intensive Care Unit (ICU) during the study period will be eligible for inclusion in the study.
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Participants - exclusion criteria
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1. Aged less than 16 years
2. Those patients who are known to be colonised at the time of admission
3. Patients who on admission are unlikely to remain in the Respiratory Intensive Care Unit (RICU) for at least 48 hours
4. Patients who are recruited, whose pre-intervention MRSA screening tests are subsequently found to be positive, will be withdrawn from the study
5. Consent declined
6. Known sensitivity to TTO
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Anticipated start date
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30/07/2007
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Anticipated end date
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30/07/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1080
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Interventions
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A proprietary 5% tea tree oil-enriched body wash preparation versus standard body wash (Johnson's pH 5.5). The duration of treatment is for the length of the patient's ICU stay. Follow up will be until hospital discharge.
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Primary outcome measure(s)
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New MRSA colonisation during the inpatient episode in RICU, as defined by detection of MRSA by conventional culture methods in screening swabs of nose and groin, or in clinical specimens processed by the laboratory in the course of normal clinical care. This will be measured on discharge from the ICU.
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Secondary outcome measure(s)
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All measured on discharge from the ICU:
1. Cost -effectiveness of regular use of 5% TTO body wash in this context
2. MRSA bacteraemia rates
3. Consumption of antibiotics used for the treatment of MRSA infection
4. Changes in the Sequential Organ Failure Assessment (SOFA) score during ICU stay
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Sources of funding
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1. The Research and Development Office, Northern Ireland (UK) (ref: EAT/3460/06)
2. REVIVE - Charity for the Regional Intensive Care Unit, Royal Victoria Hospital (UK)
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Trial website
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Publications
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Contact name
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Dr
Bronagh
Blackwood
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Address
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Nursing and Midwifery Research Unit
Queen's University Belfast
21 Stranmillis Road
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City/town
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Belfast
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Zip/Postcode
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BT9 5AF
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Country
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United Kingdom
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Tel
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+44 (0)28 9097 6551
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Email
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b.blackwood@qub.ac.uk
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Sponsor
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Belfast Health and Social Care Trust (UK)
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Address
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Royal Victoria Hospital
Grosvenor Road
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City/town
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Belfast
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Zip/Postcode
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BT12 6BA
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Country
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United Kingdom
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Tel
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+44 (0)28 9024 0503
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Email
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i.young@qub.ac.uk
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Sponsor website:
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http://www.belfasttrust.hscni.net/
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Date applied
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18/05/2007
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Last edited
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27/11/2007
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Date ISRCTN assigned
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16/08/2007
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