title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Regional Intensive Care Unit, Royal Hospitals, Belfast Health & Social Care Trust, Belfast, Northern Ireland, UK. gillian.thompson@belfasttrust.hscni.net
authors.forename: Gillian
authors.initials: G
authors.lastname: Thompson
authors.forename: Bronagh
authors.initials: B
authors.lastname: Blackwood
authors.forename: Ronan
authors.initials: R
authors.lastname: McMullan
authors.forename: Fiona A
authors.initials: FA
authors.lastname: Alderdice
authors.forename: T John
authors.initials: TJ
authors.lastname: Trinder
authors.forename: Gavin G
authors.initials: GG
authors.lastname: Lavery
authors.forename: Danny F
authors.initials: DF
authors.lastname: McAuley
mesh_terms: D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D016638:Critical Illness; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification; D012107:Research Design; D012915:Soaps / Q000191:economics / Q000627:therapeutic use*; D013207:Staphylococcal Skin Infections / Q000382:microbiology / Q000517:prevention & control*; D020947:Tea Tree Oil / Q000627:therapeutic use*
chemical_list: D000891:Anti-Infective Agents, Local; D012915:Soaps; D020947:Tea Tree Oil