A Randomized controlled trial comparing Topical use of Mupirocin versus Medihoney for the prevention of infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients
Phase 3
Suspended
- Conditions
- Peritineal Dialysis patientsRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12611000297921
- Lead Sponsor
- Department of Renal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
1. Patients on peritoneal dialysis.( Incident and prevalent)
2. Able to give informed consent
Exclusion Criteria
1. PD patients who had exit site infection, peritonitis, or tunnel infection within the last 4 weeks
2. Known hypersensitivity to, or intolerance of, honey or mupirocin.
3. On long term antibiotics for any reason.
4. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to first episode of exit site infection,peritonitis or tunnel infection -whichever comes first ( clinical assessment and microbiolgy to confirm the infection)[12 months]
- Secondary Outcome Measures
Name Time Method Secondary Endpoints : whether intervention results in: <br>a longer time to first exit site infection ( clinical assessment / microbiology)[12 months];whether intervention results in a longer time first episode of peritonitis (clinical assessment / microbiology)[12 months];a longer time to infection-associated catheter removal<br>lower catheter-associated infection rates;<br>Meausred by number of catheter removal due to infection[12 months];a lower incidence of adverse reactions ( all adverse events will be recorded and compared between the 2 groups).<br>Methods used will be questionarre and occurence of resistance ( Microbiology test)[12 months]