Colonisation with methicillin resistant Staphylococcus Aureus (MRSA)
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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