Contact information
Type
Scientific
Primary contact
Dr Bronagh Blackwood
ORCID ID
Contact details
Nursing and Midwifery Research Unit
Queen's University Belfast
21 Stranmillis Road
Belfast
BT9 5AF
United Kingdom
+44 (0)28 9097 6551
b.blackwood@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EAT/3460/06
Study information
Scientific title
Acronym
Study hypothesis
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).
Ethics approval
1. School of Nursing and Midwifery Research Ethics Committee at Queen's University Belfast, 16/04/2007, ref: 03 2007
2. Office for Research Ethics Committees Northern Ireland, 03/09/2007, ref: 07/NIR03/71
Study design
Single-centre phase II/III prospective open-label randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Critical illness; Methicillin-Resistant Staphylococcus Aureus (MRSA)
Intervention
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.
Intervention type
Drug
Phase
Phase II/III
Drug names
5% Tea Tree Oil
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
30/07/2007
Overall trial end date
30/07/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients admitted to the Intensive Care Unit (ICU) during the study period will be eligible for inclusion in the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1080
Participant exclusion criteria
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
Recruitment start date
30/07/2007
Recruitment end date
30/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nursing and Midwifery Research Unit
Belfast
BT9 5AF
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 (0)28 9024 0503
i.young@qub.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Research and Development Office, Northern Ireland (UK) (ref: EAT/3460/06)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
REVIVE - Charity for the Regional Intensive Care Unit, Royal Victoria Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19040726
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23297395
Publication citations
-
Protocol
Thompson G, Blackwood B, McMullan R, Alderdice FA, Trinder TJ, Lavery GG, McAuley DF, A randomized controlled trial of tea tree oil (5%) body wash versus standard body wash to prevent colonization with methicillin-resistant Staphylococcus aureus (MRSA) in critically ill adults: research protocol., BMC Infect. Dis., 2008, 8, 161, doi: 10.1186/1471-2334-8-161.
-
Results
Blackwood B, Thompson G, McMullan R, Stevenson M, Riley TV, Alderdice FA, Trinder TJ, Lavery GG, McAuley DF, Tea tree oil (5%) body wash versus standard care (Johnson's Baby Softwash) to prevent colonization with methicillin-resistant Staphylococcus aureus in critically ill adults: a randomized controlled trial., J. Antimicrob. Chemother., 2013, 68, 5, 1193-1199, doi: 10.1093/jac/dks501.