Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients

Phase 4

Completed

• Conditions: Peritoneal Dialysis Catheter Exit Site Infection
• Interventions: Drug: Chlorhexidine gluconate

• Registration Number: NCT02446158
• Lead Sponsor: E-DA Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2015-05
• Study First Submitted: 2015-05-10
• Study First Submitted QC: 2015-05-13
• Last Update Submitted: 2015-05-13
• Study First Posted: 2015-05-18
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine gluconate	Chlorhexidine gluconate	PD (peritoneal dialysis) paitents with daily chlorhexidine exit site care

Primary Outcome Measures

Name	Time	Method
exit site bacterial colonization status	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 Outcome Measures

Name	Time	Method
The exit-site infection rate	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.