Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients
Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedStudy Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedMarch 23, 2020
March 1, 2020
1.6 years
January 14, 2018
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exit-site/tunnel infection rate
Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
one year
Secondary Outcomes (9)
Time to the first episode of exit-site/tunnel infection
one year
peritonitis rate
one year
time to first episode of peritonitis
one year
Peritoneal dialysis infection-related hospitalization
one year
technique failure rate
one year
- +4 more secondary outcomes
Study Arms (1)
Chlorhexidine-impregnated disk
EXPERIMENTALThe chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week
Interventions
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
Eligibility Criteria
You may qualify if:
- All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital
You may not qualify if:
- patients who have known history of allergy to chlorhexidine
- patients who had previous history of peritoneal dialysis catheter exit-site infection
- patients with mentally challenging conditions who are unable to give the valid consent for the study
- patients who have been involved in another study for exit site infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singapore General Hospitallead
- Johnson & Johnsoncollaborator
Study Sites (1)
Singapore General Hospital
Singapore, 169856, Singapore
Related Publications (1)
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.
PMID: 33025409DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Htay Htay
Singapore General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2018
First Posted
January 23, 2018
Study Start
March 7, 2018
Primary Completion
October 1, 2019
Study Completion
October 25, 2019
Last Updated
March 23, 2020
Record last verified: 2020-03