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Clinical Trials/NCT01989416
NCT01989416CompletedPhase 3

Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients

Mahidol University1 site in 1 country481 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
481
Locations
1
Primary Endpoint
The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing

Study Overview

Brief Summary

The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.

Detailed Description

The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age > 18 years
  • Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours
  • Expected duration of critical care unit admission > 48 hours

Exclusion Criteria

  • History of chlorhexidine allergy

Arms & Interventions

Soap bathing

Placebo Comparator

ICU patients will be bathing with soap at least once daily

Intervention: Soap (Drug)

2% chlorhexidine wipes

Experimental

Use 2% chlorhexidine wipes to clean the patient at least once daily

Intervention: 2% chlorhexidine wipe (Drug)

Outcomes

Primary Outcomes

The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing

Time Frame: 7 days after recieved 2% chlorhexidine wipes

7 days after received 2% chlorhexidine wipes,the microbiology laboratory will process surveillance specimens using either standard culture-based at both nostrils, axillar, groins, rectum

Secondary Outcomes

  • The overall rate of hospital-acquired bloodstream infections per 1000 patient-days with chlorhexidine wipe bathing versus with soap bathing(48 hours after recieved 2% chlorhexidine wipes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adhiratha Boonyasiri

Doctor

Mahidol University

Study Sites (1)

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