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A randomised clinical trial comparing safety and efficacy of topical preparations for the eradication of methicillin resistant staphylococcus aureus (MRSA) compared with a novel preparation based on a specific blend of essential oils in surgical oncology patients. - Eradication of MRSA in surgical patients using essential oils

A randomised clinical trial comparing safety and efficacy of topical preparations for the eradication of methicillin resistant staphylococcus aureus (MRSA) compared with a novel preparation based on a specific blend of essential oils in surgical oncology patients. - Eradication of MRSA in surgical patients using essential oils

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002698-65-GB
Enrollment
110
Registered
2006-03-10
Start date
2006-04-10
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Colonisation with methicillin resistant Staphylococcus Aureus (MRSA)

Interventions

Product Name: protocol, EOB_71 Product Code: Bodywash_71 Pharmaceutical Form: Cutaneous emulsion Product Name: protocol, EOB_71 Product

Sponsors

Christie Hospital NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • (Pilot Study) Surgical Patients aged 16 years or over, colonised with MRSA who are due to receive surgery at the Christie Hospital NHS Trust requiring at least an overnight stay. • (Main Study) All patients 16 years or over identified as being MRSA+ who are due to receive surgery at the Christie Hospital NHS Trust requiring at least an overnight stay. Are the trial subjects under 18? yes 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: • Patients on relevant topical / systemic antibiotics • Patients with a history of allergy or sensitivity to relevant compounds. • (Pilot Study) Patients who have any signs of acute skin reaction from recent treatment. • (Pilot Study) Patients having any adjunctive radiotherapy or chemotherapy six weeks before or during the course of the trial.

Design outcomes

Primary

MeasureTime frame
Main Objective: • To assess the safety and clinical efficacy of a specific blend of essential oils, used in the form of an inhalation / mouthwash, a nasal gel and body wash, at clearing MRSA from patients colonised by the same bacterium and to compare efficacy with standard treatment. ; Secondary Objective: • To assess the effectiveness of the essential oil blend in reducing the number of post-operative Staphylococcus aureus/ Streptococcal wound infections • To reduce the financial burden of treating MRSA+ patients. ; Primary end point(s): Pilot study: MRSA swabs screen will be used to assess the reduction of MRSA+ swabs in surgical oncology patients, not undergoing any active treatment, colonised by MRSA, following first course of treatment using novel essential oil blend as treatment. If 0 or 1 subject only out of the 10 respond to treatment then the main study will be cancelled. Main study: MRSA swabs screen to assess the reduction of MRSA+ swabs in patients colonised by MRSA, following first course of treatment using novel essential oil blend as treatment compared to standard treatment. The statistical test of choice to assess the proportions of subjects responding in each arm is a chi square test with continuity correction.

Countries

United Kingdom

Outcome results

None listed

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