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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03692559
Other study ID # 104-032-E
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2015
Est. completion date February 3, 2017

Study information

Verified date September 2018
Source National Taiwan University Hospital Hsin-Chu Branch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.


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.


Recruitment information / eligibility

Status Completed
Enrollment 331
Est. completion date February 3, 2017
Est. primary completion date February 3, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
full aseptic dressing
Replacement of the central venous catheters in the dressing process

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Outcome

Type Measure Description Time frame Safety issue
Primary Catheter-related blood stream infections density after dressing change Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI) up to 18 months
Secondary Central Line-Associated Bloodstream Infection density after dressing change Confirm blood culture results and judge whether it is catheter related Bloodstream infection, CLABSI up to 18 months
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