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
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
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
NCT ID
NCT03692559
First Posted
October 18, 2017
Last Updated
September 30, 2018
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
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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