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Completed

NCT Number: NCT03406520

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

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

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Key information

Conditions

Peritoneal Dialysis Catheter Exit Site Infection

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169856

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: biopatch disk

Primary outcomes

  1. Exit-site/tunnel infection rate

    Time frame: one year

    Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk

Secondary outcomes

  1. Time to the first episode of exit-site/tunnel infection

    Time frame: one year

    days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection

  2. peritonitis rate

    Time frame: one year

    Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk

  3. time to first episode of peritonitis

    Time frame: one year

    days from peritoneal dialysis initiation to the time develops first episode of peritonitis

  4. Peritoneal dialysis infection-related hospitalization

    Time frame: one year

    Hospitalization due to peritoneal dialysis-related infection

  5. technique failure rate

    Time frame: one year

    technique failure is defined as transfer to hemodialysis for >= 30 days

  6. adverse events

    Time frame: one year

    any local or systemic adverse events

  7. mortality

    Time frame: one year

    all-cause mortality

  8. patient satisfaction with the use of chlorhexidine-impregnated sponge dressing

    Time frame: third month of study

    Questionnaires related to the treatment with chlorhexidine-impregnated disk

  9. comparison of the above outcomes with historical cohort using topical antibiotics cream

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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