Study protocol

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

Gillian Thompson¹ , Bronagh Blackwood² , Ronan McMullan³ , Fiona A Alderdice² , T John Trinder⁴ , Gavin G Lavery¹ and Danny F McAuley^1,5

¹Regional Intensive Care Unit, the Royal Hospitals, Belfast Health & Social Care Trust, Belfast, Northern Ireland, UK

²Nursing & Midwifery Research Unit, School of Nursing & Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK

³Department of Microbiology, the Royal Hospitals, Belfast Health & Social Care Trust, Belfast, Northern Ireland, UK

⁴Intensive Care Unit, Ulster Hospital, South Eastern Health & Social Care Trust, Belfast, Northern Ireland, UK

⁵School of Medicine, Queen's University Belfast, Belfast, Northern Ireland, UK

author email corresponding author email

BMC Infectious Diseases 2008, 8:161doi:10.1186/1471-2334-8-161

Published:	28 November 2008

Abstract

Background

Over the past ten years MRSA has become endemic in hospitals and is associated with increased healthcare costs. Critically ill patients are most at risk, in part because of the number of invasive therapies that they require in the intensive care unit (ICU). Washing with 5% tea tree oil (TTO) has been shown to be effective in removing MRSA on the skin. However, to date, no trials have evaluated the potential of TTO body wash to prevent MRSA colonization or infection. In addition, detecting MRSA by usual culture methods is slow. A faster method using a PCR assay has been developed in the laboratory, but requires evaluation in a large number of patients.

Methods/Design

This study protocol describes the design of a multicentre, phase II/III prospective open-label randomized controlled clinical trial to evaluate whether a concentration of 5% TTO is effective in preventing MRSA colonization in comparison with a standard body wash (Johnsons Baby Softwash) in the ICU. In addition we will evaluate the cost-effectiveness of TTO body wash and assess the effectiveness of the PCR assay in detecting MRSA in critically ill patients. On admission to intensive care, swabs from the nose and groin will be taken to screen for MRSA as per current practice. Patients will be randomly assigned to be washed with the standard body wash or TTO body wash. On discharge from the unit, swabs will be taken again to identify whether there is a difference in MRSA colonization between the two groups.

Discussion

If TTO body wash is found to be effective, widespread implementation of such a simple colonization prevention tool has the potential to impact on patient outcomes, healthcare resource use and patient confidence both nationally and internationally.

Trial Registration

[ISRCTN65190967]