Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients

Chlorhexidine is used in central line dressing changes and is effective in reducing line infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site infection.

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Key information

Conditions

Peritoneal Dialysis Catheter Exit Site Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

There is no consensus on what regimen is optimal for topical care of the peritoneal dialysis (PD) catheter exit site. Several methods including soap and water, povidone-iodine, hydrogen peroxide, chlorhexidine, and topical antimicrobial agents such as gentamicin or mupirocin cream have been described for care of the exit site. However, many of these studies were small or short-term and lacked longitudinal evaluation of bacterial decolonization efficacy. Staphylococcus aureus (SA) is one of most common causes of peritonitis and exit-site infection and is associated with a high PD catheter removal rate. Carriers of SA had a higher rate of exit-site infection than non-carriers. In previous studies, staphylococcal carriage prophylaxis using either mupirocin or gentimicin ointment in the nares or exit site significantly reduced the rate of exit-site infection due to SA. However, emerging antibiotic resistance is a concern. In addition, MRSA infection in PD patients is more severe than other pathogens; therefore, choosing a good antiseptic for SA and/or MRSA decolonization is important.

In recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. Data regarding chlorhexidine used in the catheter care of PD patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients > 20 years old who received PD for more than 3 months

Exclusion criteria

a history of psychological illness or condition that interferes with caring of a wound
recent (within 1 month) exit-site infection, peritonitis, or tunnel infection
recent treatment with an antibiotic administered by any route in the last month
or known hypersensitivity to or intolerance of chlorhexidine or mupirocin

Treatment and study plan

Chlorhexidine gluconate

Drug

The intervention group received daily cleaning of the exit site and application of 4% chlorhexidine (Antigerm Solution, Shining BioMedical Com. Ltd) with a swab. The chlorhexidine was rinsed off after 3 min of air drying and then gauze was applied.

Other names: Chlorhexidine

Primary outcomes

exit site bacterial colonization status

Time frame: 1 year

We performed swab cultures at the exit site and nasal site every month during follow-up at the hospital and analyzed the bacterial colonization status at 6 and 12 months as the primary outcome.

Secondary outcomes

The exit-site infection rate

Time frame: 1 year

An exit-site infection was defined by the presence of purulent drainage, with or without erythema of the skin at the catheter-epidermal interface.

Sponsors and collaborators

Lead sponsor

E-DA Hospital

Other

Registry information

Official study title

A Randomized Trial of Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients for Bacterial Decolonization and Prevention of Infection

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 18, 2015
Registry last updated: May 18, 2015

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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