A randomised controlled trial of tea tree oil (5%) body wash versus standard body wash to prevent colonisation with methicillin-resistant Staphylococcus aureus in critically ill adults
| ISRCTN | ISRCTN65190967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65190967 |
| Secondary identifying numbers | EAT/3460/06 |
- Submission date
- 18/05/2007
- Registration date
- 16/08/2007
- Last edited
- 16/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bronagh Blackwood
Scientific
Scientific
Nursing and Midwifery Research Unit
Queen's University Belfast
21 Stranmillis Road
Belfast
BT9 5AF
United Kingdom
| Phone | +44 (0)28 9097 6551 |
|---|---|
| b.blackwood@qub.ac.uk |
Study information
| Study design | Single-centre phase II/III prospective open-label randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | 5% Tea Tree Oil |
| Primary outcome measure | 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 study start date | 30/07/2007 |
| Completion date | 30/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1080 |
| Key inclusion criteria | Patients admitted to the Intensive Care Unit (ICU) during the study period will be eligible for inclusion in the study. |
| Key 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 |
| Date of first enrolment | 30/07/2007 |
| Date of final enrolment | 30/07/2010 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Nursing and Midwifery Research Unit
Belfast
BT9 5AF
United Kingdom
BT9 5AF
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Phone | +44 (0)28 9024 0503 |
|---|---|
| i.young@qub.ac.uk | |
| Website | http://www.belfasttrust.hscni.net/ |
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
The Research and Development Office, Northern Ireland (UK) (ref: EAT/3460/06)
No information available
REVIVE - Charity for the Regional Intensive Care Unit, Royal Victoria Hospital (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/11/2008 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No |
