NCT05919966

Brief Summary

We conducted a retrospective observational cohort study assessing the relationship between regular bathing using 2% CHG wipes every other day and the occurrence of central line-associated infections (CLABSI) in patients within the medical intensive care unit (MICU).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,930

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
Last Updated

June 27, 2023

Status Verified

April 1, 2023

Enrollment Period

18 days

First QC Date

June 13, 2023

Last Update Submit

June 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • central line-associated bloodstream infections

    the incidence rate of intensive care unit acquired central line-associated bloodstream infections

    Will be surveyed retrospectively through the study period (January 2017 to June 2022)

  • multidrug-resistant organisms bacteremia

    the incidence of CLABSIs with blood cultures positive for multidrug-resistant organisms

    Will be surveyed retrospectively through the study period (January 2017 to June 2022)

Secondary Outcomes (4)

  • ICU length of stay

    Will be surveyed retrospectively through the study period (January 2017 to June 2022)

  • hospital length of stay

    Will be surveyed retrospectively through the study period (January 2017 to June 2022)

  • ICU mortality

    Will be surveyed retrospectively through the study period (January 2017 to June 2022)

  • hospital mortality

    Will be surveyed retrospectively through the study period (January 2017 to June 2022)

Study Arms (2)

chlorhexidine group

Patients were bathed one day involving the use of wipes soaked in a 2% chlorhexidine gluconate (CHG) solution and the next day using a towel soaked with water and soap during the MICU stays.

Other: Chlorhexidine bathing

usual care group

Patients were bathed with towels soaked in water and soap on a daily basis during the MICU stays.

Interventions

The procedure involved pouring an entire bottle (200ml) of 2% CHG solution (PBF Biotech, Taipei, Taiwan) onto a pre-packed set of eight single-use cotton wipes before each bathing session. A minimum of six wipes were required to thoroughly cover the entire body, including the bilateral upper and lower extremities, front and back of the trunk, perineum, and buttocks.

chlorhexidine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study included all patients aged eighteen years and older who were admitted to the MICU between January 2017 and June 2022, without any exclusions based on specific disease characteristics.

You may qualify if:

  • all patients who were admitted to the MICU between January 2017 and June 2022

You may not qualify if:

  • patients aged under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Yi-Chen Lin

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 27, 2023

Study Start

April 12, 2023

Primary Completion

April 30, 2023

Study Completion

May 30, 2023

Last Updated

June 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations