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

September 30, 2018 updated by: Teng,Meng-Lan Head Nurse, National Taiwan University Hospital Hsin-Chu Branch
The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

331

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: full sterile dressing
Patients receive full sterile dressing
Other: full aseptic dressing
Replacement of the central venous catheters in the dressing process
NO_INTERVENTION: usual standard care
Patients receive usual standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Investigators

  • Study Chair: Meng-lan Teng, National Taiwan University Hospital Hsin-Chu Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2015

Primary Completion (ACTUAL)

February 3, 2017

Study Completion (ACTUAL)

February 3, 2017

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

September 30, 2018

First Posted (ACTUAL)

October 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 30, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-032-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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