Peritoneal Dialysis Catheter Exit Site Infection
Conditions
Keywords
peritoneal dialysis, chlorhexidine, exit site infection, tunnel tract infection
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.
Interventions
DEVICEChlorhexidine-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
Sponsors
Johnson & Johnson
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exit-site/tunnel infection rate | one year | Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peritonitis rate | one year | Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk |
| time to first episode of peritonitis | one year | days from peritoneal dialysis initiation to the time develops first episode of peritonitis |
| Peritoneal dialysis infection-related hospitalization | one year | Hospitalization due to peritoneal dialysis-related infection |
| technique failure rate | one year | technique failure is defined as transfer to hemodialysis for \>= 30 days |
| Time to the first episode of exit-site/tunnel infection | one year | days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection |
| mortality | one year | all-cause mortality |
| patient satisfaction with the use of chlorhexidine-impregnated sponge dressing | third month of study | Questionnaires related to the treatment with chlorhexidine-impregnated disk |
| comparison of the above outcomes with historical cohort using topical antibiotics cream | one year | 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 |
| adverse events | one year | any local or systemic adverse events |
Countries
Singapore
Outcome results
None listed