Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent
      infections in patients that need renal dialysis. A maximum of fifty subjects will be
      recruited and will be assessed for signs of infection once per week for the first 6 weeks and
      then every 4 weeks until week 26. They will also be checked for nasal carriage of 'Golden
      Staph' when they enroll in the trial. The subjects will complete the trial if they have 26
      weeks infection-free or if they have an infection during that period
    

Detailed description: 
      The patients for the trial are to be recruited in the Renal Unit at SCGH and at enrolment a
      nasal swab is taken to see if the patients has nasal carriage of S. aureus. The patient is
      also given a prescription for 5% TTO nasal ointment which was filled by the SCGH pharmacy.
      The application of medication will follow the usual procedure which consists of bi-daily
      nasal application for 5 days and then weekly application for the next 25 weeks of the trial.
      The patients are not blinded and are given all their medication at one dispensing which
      consists of 3 × 10 g tubes of 5% TTO. The patients have weekly assessments for the first 6
      weeks of the trial and then 4 weekly assessments until week 26. All assessments are conducted
      during routine dressing changes or routine visits and are conducted by specially trained
      dialysis nurses. During each visit the catheter site is examined for any signs of infection
      and the findings documented on a questionnaire. Suspected cases of infection are identified
      by trained nurses and the consultant physician will then examined the patient. The findings
      will be documented by the nurse on a questionnaire and submitted to the primary investigator
      for review, confirmation, and classification. The primary endpoint is the proportion of
      patients with a catheter-related infection within 6 months after entry into the study. The
      infections included: (1) exit site infection (ESI); (2) tunnel infections; and (3)
      bacteraemia. The endpoint is evaluated by the primary investigator according to the
      definitions for catheter-related infections. Cases with "definite" and "probable" infections
      will be classified as infections.

      All catheter-related infections are treated by the patient's nephrologist according to their
      usual practice. If a new catheter is clinically indicated, the patient will continued to
      receive the same ointment to which they had been assigned. Swabs for cultures and
      sensitivities at the catheter exit site are taken if an exit or tunnel infection is suspected
      and blood cultures if a bacteraemia is suspected. All microbiology samples will be sent to
      the PathWest laboratory for culture and sensitivities. The study will end when the last
      enrolled subject has completed the minimum 6-month study period.
    

Intervention name(s): 5% tea tree oil nasal ointment
Intervention type(s): Drug
Intervention description(s): daily for 5 days then weekly for 6 months
Intervention MeSH terms: Tea Tree Oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: haemodialysis; peritoneal dialysis