Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
Primary Purpose
Peritoneal Dialysis Catheter Exit Site Infection
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Sponsored by

About this trial
This is an interventional prevention trial for Peritoneal Dialysis Catheter Exit Site Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chlorhexidine gluconate
Control group
Arm Description
PD (peritoneal dialysis) paitents with daily chlorhexidine exit site care
PD (peritoneal dialysis) patients with usual (Normal saline) exit site care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02446158
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E-DA Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis Catheter Exit Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine gluconate
Arm Type
Experimental
Arm Description
PD (peritoneal dialysis) paitents with daily chlorhexidine exit site care
Arm Title
Control group
Arm Type
No Intervention
Arm Description
PD (peritoneal dialysis) patients with usual (Normal saline) exit site care
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Chlorhexidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
exit site bacterial colonization status
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The exit-site infection rate
Description
An exit-site infection was defined by the presence of purulent drainage, with or without erythema of the skin at the catheter-epidermal interface.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
28981543
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.
Results Reference
derived
Learn more about this trial
Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
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