Condition category
Infections and Infestations
Date applied
18/05/2007
Date assigned
16/08/2007
Last edited
16/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.belfasttrust.hscni.net/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes