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IRCT20110427006318N10 IRCT 2019-01-17 Semnan University of Medical Sciences The effect of propolis on the incidence of peritonitis in patients on continuous ambulatory peritoneal dialysis The effect of propolis on the incidence of peritonitis in patients on continuous ambulatory peritoneal dialysis 2019-02-04 anticipated 90 Complete https://irct.ir/trial/36505 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research sample assigned to the groups of the study by permuted blocks randomization. Also blocking is used within age and frequency of dialysis during the day strata, Blinding description: Propolsis ointment is provided as a blind to a dialyser. Also the data analyst is blind. N/A Peritonitis. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data is confidential.
public Monir Nobahar
Semnan, University of Medical Sciences, Nursing and Midwifery
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@semums.ac.ir Semnan University of Medical Sciences scientific Monir Nobahar
Semnan, University of Medical Sciences, Nursing and Midwifery
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) 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 Lack of history of hypersensitivity to honey 18 years 60 years Both Other sites of infections Catheter exit site infection Tunnel infection or peritonitis in the previous month Antibiotic therapy over the past four weeks Carriers of staphylococcus aureus History of psychiatric illness Cognitive disorder K65.0 Generalized (acute) peritonitis Prevention Prevention 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. 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. Timepoint: The patient will be assessed every two weeks for peritoneal dialysis. An aliquot of peritoneal effluent and a swab of exit site will be sent for culture monthly and in occasion of appearance of exit site secretion or peritonitis. The duration of assessment will continue for 6 months. Method of measurement: Symptoms of peritonitis are evaluated according to the International Society for Peritoneal Dialysis (ISPD) criteria. Exit site of catheter and tunnel are monitored for signs of infection (redness, pain, warmness and swelling, secretion from the exit site of the catheter). Timepoint: The patient will be assessed every two weeks for infection signs. 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. Method of measurement: Inspection of redness, pain, warmness and swelling, secretion from the exit site of the catheter. Semnan University of Medical Sciences Approved 2018-11-20 Ethics committee of Semnan University of Medical sciences Semnan University of Medical Sciences, Basij Blv, Semnan Semnan Semnan Iran (Islamic Republic of)