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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
E-DA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peritoneal Dialysis Catheter Exit Site Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 10, 2015
    Last Updated
    May 13, 2015
    Sponsor
    E-DA Hospital
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    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

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    Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients

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