Clinical trial NCT02446158: Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
Official title: A Randomized Trial of Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients for Bacterial Decolonization and Prevention of Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peritoneal Dialysis Catheter Exit Site Infection
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: exit site bacterial colonization status
timeFrame: 1 year
Secondary outcomes:
measure: The exit-site infection rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Wang HH, Hung SY, Chang MY, Lee YC, Lin HF, Lin TM, Yang SP, Lin HH, Yang SC, Wang JL. Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis patients-A prospective, randomized controlled trial. PLoS One. 2017 Oct 5;12(10):e0184859. doi: 10.1371/journal.pone.0184859. eCollection 2017.