Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
1 other identifier
interventional
481
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2013
Shorter than P25 for phase_3
1 active site
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
First Submitted
Initial submission to the registry
October 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedDecember 2, 2015
November 1, 2015
1.1 years
October 13, 2013
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing
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 Outcomes (1)
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
Study Arms (2)
Soap bathing
PLACEBO COMPARATORICU patients will be bathing with soap at least once daily
2% chlorhexidine wipes
EXPERIMENTALUse 2% chlorhexidine wipes to clean the patient at least once daily
Interventions
The ICU patients will be bathing with 2% chlorhexidine wipe
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of chlorhexidine allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
Boonyasiri A, Thaisiam P, Permpikul C, Judaeng T, Suiwongsa B, Apiradeewajeset N, Fakthongphan T, Suddee S, Laoagtipparos W, Thamlikitkul V. Effectiveness of Chlorhexidine Wipes for the Prevention of Multidrug-Resistant Bacterial Colonization and Hospital-Acquired Infections in Intensive Care Unit Patients: A Randomized Trial in Thailand. Infect Control Hosp Epidemiol. 2016 Mar;37(3):245-53. doi: 10.1017/ice.2015.285.
PMID: 26894621DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adhiratha Boonyasiri, MD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 13, 2013
First Posted
November 21, 2013
Study Start
December 1, 2013
Primary Completion
January 1, 2015
Study Completion
April 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-11