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

NCT ID: NCT03692559

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-20

Study Completion Date

2017-02-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Central Line-associated Bloodstream Infection (CLABSI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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full sterile dressing

Patients receive full sterile dressing

Group Type EXPERIMENTAL

full aseptic dressing

Intervention Type OTHER

Replacement of the central venous catheters in the dressing process

usual standard care

Patients receive usual standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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full aseptic dressing

Replacement of the central venous catheters in the dressing process

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Teng,Meng-Lan Head Nurse

Head Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meng-lan Teng

Role: STUDY_CHAIR

National Taiwan University Hospital Hsin-Chu Branch

Other Identifiers

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104-032-E

Identifier Type: -

Identifier Source: org_study_id

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