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

Not Applicable

Completed

• Conditions: Central Line-associated Bloodstream Infection (CLABSI)
• Interventions: Other: full aseptic dressing

• Registration Number: NCT03692559
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

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.

Study Timeline

• Study Start: 2015-08-20
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Study First Submitted: 2017-10-18
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-30
• Last Update Submitted: 2018-09-30
• Study First Posted: 2018-10-02
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
full sterile dressing	full aseptic dressing	Patients receive full sterile dressing

Primary Outcome Measures

Name	Time	Method
Catheter-related blood stream infections density after dressing change	up to 18 months	Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI)

Secondary Outcome Measures

Name	Time	Method
Central Line-Associated Bloodstream Infection density after dressing change	up to 18 months	Confirm blood culture results and judge whether it is catheter related Bloodstream infection, CLABSI