Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients

Peritoneal Dialysis Catheter Exit Site Infection Clinical Trial

Official title:

Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406520
• Other study ID #: SRG-NIG#08/2017
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: October 25, 2019

Study information

• Verified date: March 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 25, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Peritoneal Dialysis Catheter Exit Site Infection

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Johnson & Johnson

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	peritonitis rate	Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk	one year
Secondary	time to first episode of peritonitis	days from peritoneal dialysis initiation to the time develops first episode of peritonitis	one year
Secondary	Peritoneal dialysis infection-related hospitalization	Hospitalization due to peritoneal dialysis-related infection	one year
Secondary	technique failure rate	technique failure is defined as transfer to hemodialysis for >= 30 days	one year
Secondary	adverse events	any local or systemic adverse events	one year
Secondary	mortality	all-cause mortality	one year
Secondary	patient satisfaction with the use of chlorhexidine-impregnated sponge dressing	Questionnaires related to the treatment with chlorhexidine-impregnated disk	third month of study
Secondary	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