NCT03406520

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peritoneal Dialysis Catheter Exit Site Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-07
• Primary completion: 2019-10-01
• Completion: 2019-10-25
• First posted: 2018-01-23
• Last updated: 2020-03-23

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated device study