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

Central Line-associated Bloodstream Infection (CLABSI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692559
• Other study ID #: 104-032-E
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Central Line-associated Bloodstream Infection (CLABSI)
• Communicable Diseases
• Infection

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