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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 - Effectiveness of tea tree oil in preventing colonization with MRSA

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 - Effectiveness of tea tree oil in preventing colonization with MRSA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002853-21-GB
Enrollment
1080
Registered
2007-08-01
Start date
2007-09-03
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonization with methicillin-resistant Staphylococcus aureus (MRSA)

Interventions

Trade Name: Novabac antibacterial skin wash Product Name: Novabac antibacterial skin wash Pharmaceutical Form: Cutaneous liquid Pharmaceutical form of t

Sponsors

Belfast Health & Social Care Trust
Lead Sponsor
South Eastern Health & Social Care Trust
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients admitted to the Regional Intensive Care Unit at the Belfast Health & Social Care Trust (Royal Victoria Hospital, Belfast) and the Intensive Care Unit at the South Eastern Health & social Care Trust (Ulster Hospital, Dundonald) during the study period will be eligible for inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Age < 18 years. 2. Those patients who are known to be colonized at the time of admission. 3. Patients who on admission are unlikely to remain in the ICU 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 Patients who are recruited, whose pre-intervention MRSA screening tests are subsequently found to be positive will be withdrawn from the study. 5.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.

Design outcomes

Primary

MeasureTime frame
Main Objective: The hypothesis of the study is that treatment with tea tree oil (Novabac) can prevent colonisation with MRSA in critically ill adults. The primary outcome is the incidence of new MRSA colonization. ; Secondary Objective: The secondary objectives are to 1) investigate if treatment with tea tree oil is more cost-effective than standard body wash (Johnston’s softwash). 2) investigate if the is no difference in sensitivity and specificity between a PCR-based assay for detection of colonization with MRSA and the standard culture method. ;Primary end point(s): The primary outcome measure will be MRSA colonization at ICU discharge, measured using standard culture techniques

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026