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Study aim: To determine the effect of propolis on rate of peritonitis due to catheter in continuous peritoneal dialysis. Design: Clinical Trial, by using block randomization, the Patients enter in intervention, control, or placebo group. Parallel groups, double blind. Settings and conduct: A study is conducted in Tehran's Shafa Hospital. Propolsis ointment is provided as a blind to a dialyser. Also the data analyst is blind. The patient will be assessed every two weeks for peritoneal dialysis. Monthly and with signs of infection and peritonitis, the culture of the catheter exit site and the dialysis output fluid will be sent for 6 months. Participants/Inclusion and exclusion criteria: Inclusion criteria: Patients aged 18-60 years; at least history of three months peritoneal dialysis; lack of acute infections; at least 2-4 sessions of peritoneal dialysis per day; and lack of history of hypersensitivity to honey. Exclusion criteria: Other infections; catheter exit site infection; tunnel infection or peritonitis in the previous month; antibiotic therapy in the past four weeks; carriers of staphylococcus aureus; history of psychiatric illness and cognitive disorder. Intervention groups: Intervention group: Every other day; in the morning after the dialysis the site of the catheter is washed with 0.9% normal saline and then 10% of the propolis ointment is used for 6 months. Control group: Every other day; in the morning after the dialysis the site of the catheter is washed with 0.9% normal saline and then 2% Mupirocin ointment is used for 6 months. In the placebo group: The catheter site was rinsed with 0.9% normal saline for 6 months. Main outcome variables: Peritonitis is evaluated in the presence of Cloudy fluid, abdominal pain, white blood cell count of more than 100/ mm3 (at least 50% neutrophils), fever, and positive fluid dialysis culture.
IRCTID: IRCT20110427006318N10
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