An interventional study of Chlorhexidine-impregnated disk in Peritoneal Dialysis Catheter Exit Site Infection, sponsored by Singapore General Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Prevention
The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients
The primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing.
The participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. Each participant will be followed up for one year.
Exclusion Criteria:
The chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week
Device: Chlorhexidine-impregnated disk
The chlorhexidine-impregnated sponge, named biopatch, is a protective disk (2.5 cm x 0.7 cm), which is hydrophilic polyurethane absorptive foam with chlorhexidine gluconate, in average of 86.8mg per disk
Also known as: biopatch disk
Exit-site/tunnel infection rate
Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
Time frame: one year
Time to the first episode of exit-site/tunnel infection
days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection
Time frame: one year
peritonitis rate
Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
Time frame: one year
time to first episode of peritonitis
days from peritoneal dialysis initiation to the time develops first episode of peritonitis
Time frame: one year
Peritoneal dialysis infection-related hospitalization
Hospitalization due to peritoneal dialysis-related infection
Time frame: one year
technique failure rate
technique failure is defined as transfer to hemodialysis for \>= 30 days
Time frame: one year
adverse events
any local or systemic adverse events
Time frame: one year
mortality
all-cause mortality
Time frame: one year
patient satisfaction with the use of chlorhexidine-impregnated sponge dressing
Questionnaires related to the treatment with chlorhexidine-impregnated disk
Time frame: third month of study
comparison of the above outcomes with historical cohort using topical antibiotics cream
comparison of exit-site/tunnel infection rate, peritonitis rate, time to first episode of exit-site/tunnel infection or peritonitis, technique failure rate, hospitalization rate, adverse events, mortality with historical cohort patients using topical gentamicin cream
Time frame: one year
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Singapore General Hospital