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The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections

Primary Purpose

Central Line-associated Bloodstream Infection (CLABSI)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
full aseptic dressing
Sponsored by
National Taiwan University Hospital Hsin-Chu Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Central Line-associated Bloodstream Infection (CLABSI) focused on measuring CRBSI, CLABSI

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults older than 20 years old
  • Patients with central venous catheters
  • Agree to participate in this study, and fill out the study consent

Exclusion Criteria:

  • PICC patients placed
  • Patients with bloodstream infection
  • Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    full sterile dressing

    usual standard care

    Arm Description

    Patients receive full sterile dressing

    Patients receive usual standard care

    Outcomes

    Primary Outcome Measures

    Catheter-related blood stream infections density after dressing change
    Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI)

    Secondary Outcome Measures

    Central Line-Associated Bloodstream Infection density after dressing change
    Confirm blood culture results and judge whether it is catheter related Bloodstream infection, CLABSI

    Full Information

    First Posted
    October 18, 2017
    Last Updated
    September 30, 2018
    Sponsor
    National Taiwan University Hospital Hsin-Chu Branch
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03692559
    Brief Title
    The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections
    Official Title
    The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 20, 2015 (Actual)
    Primary Completion Date
    February 3, 2017 (Actual)
    Study Completion Date
    February 3, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taiwan University Hospital Hsin-Chu Branch

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.
    Detailed Description
    The study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern Taiwan. The investigators used block randomization to assign patients to the study group or control group. In study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. Study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. The investigators defined the infection outcome according to culture results, and the guidelines by Infectious Diseases Society of America and Centers for Disease Control and Prevention, USA. Analysis was done by SPSS version 23. The investigators used percentage and average to study characteristics of participants. The investigators used Chi-Square or Fisher's exact test and Poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. The investigators used Kaplan-Meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. The investigators used logistic regression model to analyze factors associated with development of bloodstream infections.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Line-associated Bloodstream Infection (CLABSI)
    Keywords
    CRBSI, CLABSI

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    331 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    full sterile dressing
    Arm Type
    Experimental
    Arm Description
    Patients receive full sterile dressing
    Arm Title
    usual standard care
    Arm Type
    No Intervention
    Arm Description
    Patients receive usual standard care
    Intervention Type
    Other
    Intervention Name(s)
    full aseptic dressing
    Intervention Description
    Replacement of the central venous catheters in the dressing process
    Primary Outcome Measure Information:
    Title
    Catheter-related blood stream infections density after dressing change
    Description
    Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI)
    Time Frame
    up to 18 months
    Secondary Outcome Measure Information:
    Title
    Central Line-Associated Bloodstream Infection density after dressing change
    Description
    Confirm blood culture results and judge whether it is catheter related Bloodstream infection, CLABSI
    Time Frame
    up to 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults older than 20 years old Patients with central venous catheters Agree to participate in this study, and fill out the study consent Exclusion Criteria: PICC patients placed Patients with bloodstream infection Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meng-lan Teng
    Organizational Affiliation
    National Taiwan University Hospital Hsin-Chu Branch
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections

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