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Completed

NCT Number: NCT03692559

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

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

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Key information

Conditions

Central Line-associated Bloodstream Infection (CLABSI)

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

full aseptic dressing

Other

Replacement of the central venous catheters in the dressing process

Primary outcomes

  1. Catheter-related blood stream infections density after dressing change

    Time frame: up to 18 months

    Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI)

Secondary outcomes

  1. Central Line-Associated Bloodstream Infection density after dressing change

    Time frame: up to 18 months

    Confirm blood culture results and judge whether it is catheter related Bloodstream infection, CLABSI

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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