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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine-impregnated disk | Experimental | The chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine-impregnated disk | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exit-site/tunnel infection rate | Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first episode of exit-site/tunnel infection | days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection | one year |
| peritonitis rate | Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Htay Htay | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | 169856 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33025409 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2017 | Jan 12, 2018 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2022 | Dec 21, 2022 | 4 | ||
| Apr 29, 2024 |
Prospective cohort study
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|
| one year |
| time to first episode of peritonitis | days from peritoneal dialysis initiation to the time develops first episode of peritonitis | one year |
| Peritoneal dialysis infection-related hospitalization | Hospitalization due to peritoneal dialysis-related infection | one year |
| technique failure rate | technique failure is defined as transfer to hemodialysis for >= 30 days | one year |
| adverse events | any local or systemic adverse events | one year |
| mortality | all-cause mortality | one year |
| patient satisfaction with the use of chlorhexidine-impregnated sponge dressing | Questionnaires related to the treatment with chlorhexidine-impregnated disk | 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 | one year |
| May 24, 2024 |
| 5 |