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

November 30, 2015 updated by: Adhiratha Boonyasiri, Mahidol University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

481

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

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

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Soap bathing
ICU patients will be bathing with soap at least once daily
Drug: Soap
The ICU patients will be bathing with Soap
Other Names:
  • Control soap
EXPERIMENTAL: 2% chlorhexidine wipes
Use 2% chlorhexidine wipes to clean the patient at least once daily
Drug: 2% chlorhexidine wipe
The ICU patients will be bathing with 2% chlorhexidine wipe
Other Names:
  • chlorhexidine wipe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days after recieved 2% chlorhexidine wipes

Secondary Outcome Measures

Outcome Measure
Time Frame
The overall rate of hospital-acquired bloodstream infections per 1000 patient-days with chlorhexidine wipe bathing versus with soap bathing
Time Frame: 48 hours after recieved 2% chlorhexidine wipes
48 hours after recieved 2% chlorhexidine wipes

Collaborators and Investigators

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

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2013

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

October 13, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 567-2556-EC4

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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