- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364435
Effect of Bed Bathing Methods on VRE Colonization in ICU Patients
The Effect of Two Different Bed Bathing Methods on Vancomycin-Resistant Enterococcus Colonization in Intensive Care Patients: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a randomized controlled trial conducted in the general intensive care units of a tertiary care hospital. Adult patients meeting the inclusion criteria were randomly assigned to one of two parallel groups. The experimental group received daily whole-body bed bathing with a 4% chlorhexidine gluconate solution, while the control group received daily bed bathing using disposable antibacterial body cleansing wipes.
Randomization was performed to ensure comparable baseline characteristics between the groups. VRE colonization was assessed through skin swab cultures obtained at baseline and subsequently on days 7, 14, and 21. The primary outcome of the study was the rate of VRE colonization over time. Secondary analyses included the evaluation of patient-related factors such as age, length of stay, body mass index, and previous VRE history.
All procedures were performed by trained nursing staff according to standardized protocols. The study was conducted following ethical approval obtained from the institutional ethics committee, and informed consent was obtained in accordance with ethical standards. The findings of this study aim to support evidence-based infection control practices in intensive care nursing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34000
- Basaksehir Pine and Sakura City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients admitted to the intensive care unit
- Expected ICU stay of at least 48 hours
- Patients requiring daily bed bathing
Exclusion Criteria:
- Known hypersensitivity to chlorhexidine
- Extensive skin lesions or burns
- Patients colonized or infected with VRE at ICU admission
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Disposable Antibacterial Bed Bath Wipes
Participants receive daily bed bathing using disposable antibacterial body cleansing wipes.
|
Daily whole-body bed bathing using disposable antibacterial body cleansing wipes as part of routine ICU care.
Other Names:
|
|
Experimental: 4% Chlorhexidine Gluconate Bed Bath
Participants receive daily whole-body bed bathing using a 4% chlorhexidine gluconate solution as part of the bed bathing procedure.
|
Daily whole-body bed bathing performed as part of routine ICU care.
Other Names:
A 4% chlorhexidine gluconate solution used during the bed bathing procedure for whole-body skin antisepsis in ICU patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vancomycin-Resistant Enterococcus (VRE) Colonization
Time Frame: Baseline, Day 7, Day 14, and Day 21
|
The presence of vancomycin-resistant Enterococcus (VRE) colonization assessed by skin swab cultures obtained from intensive care unit patients.
Cultures were collected at baseline and on days 7, 14, and 21 to compare the effect of two different bed bathing methods.
|
Baseline, Day 7, Day 14, and Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in VRE Colonization Over Time
Time Frame: Day 7, Day 14, and Day 21
|
Changes in VRE colonization status over time were evaluated to assess the temporal effect of bed bathing methods during intensive care unit stay.
|
Day 7, Day 14, and Day 21
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayfer Ozbas, Prof.Dr., T.C. DEMIROGLU SCIENCE UNIVERSITY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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