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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05919966
Other study ID # 202302031RINC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2023
Est. completion date May 30, 2023

Study information

Verified date April 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

This study defined the post-intervention period as July 1, 2017, to June 30, 2022. During this period, one of the three medical intensive care units (MICUs) in NTUH implemented chlorhexidine gluconate (CHG) bathing as part of their daily care routine (CHG group). This decision was made in response to a higher incidence rate of vancomycin-resistant Enterococcus (VRE) bacteremia observed in that particular MICU during the preceding six months (pre-intervention period: January 1, 2017, to June 30, 2017), compared to the other two MICUs. The remaining two MICUs continued to provide usual care, which involved bathing patients with towels soaked in water and soap on a daily basis.


Recruitment information / eligibility

Status Completed
Enrollment 6930
Est. completion date May 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients who were admitted to the MICU between January 2017 and June 2022 Exclusion Criteria: - patients aged under 18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chlorhexidine bathing
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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 ICU length of stay the total duration of the patient's ICU stay (days) Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Secondary hospital length of stay the total duration of the patient's hospital stay (days) Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Secondary ICU mortality whether the patient has died during their stay in the ICU Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Secondary hospital mortality whether the patient has died during their stay in the hospital Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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