- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446158
Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
A Randomized Trial of Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients for Bacterial Decolonization and Prevention of Infection
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chlorhexidine gluconate
PD (peritoneal dialysis) paitents with daily chlorhexidine exit site care
|
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:
|
No Intervention: Control group
PD (peritoneal dialysis) patients with usual (Normal saline) exit site care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDAHP99020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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