Clinical trial NCT03406520: Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients
Official title: Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis Catheter Exit Site Infection
Keywords: peritoneal dialysis
chlorhexidine
exit site infection
tunnel tract infection
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2018-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital

Exclusion Criteria:

1. patients who have known history of allergy to chlorhexidine
2. patients who had previous history of peritoneal dialysis catheter exit-site infection
3. patients with mentally challenging conditions who are unable to give the valid consent for the study
4. patients who have been involved in another study for exit site infection

Primary outcomes:
measure: Exit-site/tunnel infection rate
timeFrame: one year
Secondary outcomes:
measure: Time to the first episode of exit-site/tunnel infection
timeFrame: one year
measure: peritonitis rate
timeFrame: one year
measure: time to first episode of peritonitis
timeFrame: one year
measure: Peritoneal dialysis infection-related hospitalization
timeFrame: one year
measure: technique failure rate
timeFrame: one year
measure: adverse events
timeFrame: one year
measure: mortality
timeFrame: one year
measure: patient satisfaction with the use of chlorhexidine-impregnated sponge dressing
timeFrame: third month of study
measure: comparison of the above outcomes with historical cohort using topical antibiotics cream
timeFrame: one year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Htay Htay
role: PRINCIPAL_INVESTIGATOR
References:
citation: Htay H, Choo JCJ, Johnson DW, Pascoe EM, Jayaballa M, Oei EL, Ng LC, Wu SY, Foo MWY. Chlorhexidine-impregnated sponge dressing for prevention of catheter exit-site infection in peritoneal dialysis patients: a pilot study. Int Urol Nephrol. 2021 Apr;53(4):803-812. doi: 10.1007/s11255-020-02674-w. Epub 2020 Oct 6.