Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients

Peritoneal Dialysis Catheter Exit Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446158
• Other study ID #: EDAHP99020
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2015
• Last updated: May 13, 2015
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2015
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peritoneal Dialysis Catheter Exit Site Infection

Intervention

Drug:
• Chlorhexidine gluconate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exit site bacterial colonization status	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.	1 year	Yes
Secondary	The exit-site infection rate	An exit-site infection was defined by the presence of purulent drainage, with or without erythema of the skin at the catheter-epidermal interface.	1 year	Yes