Vancomycin-Resistant EnterococcusNCT07364435
Effect of Bed Bathing Methods on VRE Colonization in ICU Patients
A study testing Bed Bath, Disposable antibacterial bed bath wipes and Chlorhexidine gluconate 4% in people with Vancomycin-Resistant Enterococcus, run by Özkan Kasap at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the effects of two different bed bathing methods on vancomycin-resistant Enterococcus (VRE) colonization in adult intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin-Resistant Enterococcus
- What is being tested?
- Bed Bath, Disposable antibacterial bed bath wipes and Chlorhexidine gluconate 4%
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known hypersensitivity to chlorhexidine
- Extensive skin lesions or burns
- Patients colonized or infected with VRE at ICU admission
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Pine and Sakura City Hospital
Istanbul, Istanbul, 34000
About this study
Official title: The Effect of Two Different Bed Bathing Methods on Vancomycin-Resistant Enterococcus Colonization in Intensive Care Patients: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effects of two different bed bathing methods on vancomycin-resistant Enterococcus (VRE) colonization in adult intensive care unit patients. A total of 210 patients were randomly assigned to receive either daily whole-body bathing with 4% chlorhexidine gluconate solution or daily bed bathing using disposable antibacterial body wipes. VRE colonization was monitored using skin swab cultures collected on days 7, 14, and 21. The results of this study may contribute to infection prevention strategies in intensive care units by identifying effective hygiene practices for reducing VRE colonization.
Read the 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.
- Conditions
- Vancomycin-Resistant Enterococcus
- Being tested
- Bed Bath, Disposable antibacterial bed bath wipes, Chlorhexidine gluconate 4%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed BathProcedure or surgery
Also called Daily whole-body bathing with 4% chlorhexidine gluconate solution.
Daily whole-body bed bathing performed as part of routine ICU care.
Disposable antibacterial bed bath wipesDevice
Also called Daily bed bathing using disposable antibacterial body cleansing wipes., Antibacterial bathing wipes
Daily whole-body bed bathing using disposable antibacterial body cleansing wipes as part of routine ICU care.
Chlorhexidine gluconate 4%Drug
Also called CHG 4% solution
A 4% chlorhexidine gluconate solution used during the bed bathing procedure for whole-body skin antisepsis in ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| 4% Chlorhexidine Gluconate Bed Bath | Experimental | Participants receive daily whole-body bed bathing using a 4% chlorhexidine gluconate solution as part of the bed bathing procedure. Receives: Procedure: Bed Bath; Drug: Chlorhexidine gluconate 4% |
| Disposable Antibacterial Bed Bath Wipes | Active comparator | Participants receive daily bed bathing using disposable antibacterial body cleansing wipes. Receives: Device: Disposable antibacterial bed bath wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancomycin-Resistant Enterococcus (VRE) Colonization
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.
Measured: Baseline, Day 7, Day 14, and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Sep 2024
- Primary completion1 Jan 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vancomycin-Resistant EnterococcusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özkan Kasap
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Özkan Kasap, Başakşehir Çam & Sakura City Hospital
- Investigators
- Ayfer Ozbas, Prof.Dr., Principal investigator, T.C. DEMIROGLU SCIENCE UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364435
- Sponsor's protocol ID
- 2024-188
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2026
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This study was conducted as a single-center academic randomized controlled trial, and the informed consent and ethics committee approval did not include provisions for public data sharing. All data are analyzed and reported in aggregate form to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Bed Bathing Methods on Vancomycin-Resistant Enterococcus Colonization in Intensive Care Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07364435
- Acronym / sponsor ID
- 2024-188
- Conditions
- Vancomycin-Resistant Enterococcus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Özkan KasapOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare the effects of two different bed bathing methods on vancomycin-resistant Enterococcus (VRE) colonization in adult intensive care unit patients. A total of 210 patients were randomly assigned to receive either daily whole-body bathing with 4% chlorhexidine gluconate solution or daily bed bathing using disposable antibacterial body wipes. VRE colonization was monitored using skin swab cultures collected on days 7, 14, and 21. The results of this study may contribute to infection prevention strategies in intensive care units by identifying effective hygiene practices for reducing VRE colonization.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4% Chlorhexidine Gluconate Bed Bath | Experimental | Procedure: Bed Bath, Drug: Chlorhexidine gluconate 4%Participants receive daily whole-body bed bathing using a 4% chlorhexidine gluconate solution as part of the bed bathing procedure. |
| Disposable Antibacterial Bed Bath Wipes | Active comparator | Device: Disposable antibacterial bed bath wipesParticipants receive daily bed bathing using disposable antibacterial body cleansing wipes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Known hypersensitivity to chlorhexidine
- Extensive skin lesions or burns
- Patients colonized or infected with VRE at ICU admission
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed BathAlso: Daily whole-body bathing with 4% chlorhexidine gluconate solution.Daily whole-body bed bathing performed as part of routine ICU care. | Procedure or surgery | 4% Chlorhexidine Gluconate Bed Bath |
| Disposable antibacterial bed bath wipesAlso: Daily bed bathing using disposable antibacterial body cleansing wipes., Antibacterial bathing wipesDaily whole-body bed bathing using disposable antibacterial body cleansing wipes as part of routine ICU care. | Device | Disposable Antibacterial Bed Bath Wipes |
| Chlorhexidine gluconate 4%Also: CHG 4% solutionA 4% chlorhexidine gluconate solution used during the bed bathing procedure for whole-body skin antisepsis in ICU patients. | Drug | 4% Chlorhexidine Gluconate Bed Bath |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This study was conducted as a single-center academic randomized controlled trial, and the informed consent and ethics committee approval did not include provisions for public data sharing. All data are analyzed and reported in aggregate form to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayfer Ozbas, Prof.Dr. principal investigator
T.C. DEMIROGLU SCIENCE UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed Bath, Disposable antibacterial bed bath wipes and Chlorhexidine gluconate 4% in people with Vancomycin-Resistant Enterococcus, run by Özkan Kasap at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancomycin-Resistant Enterococcus (VRE) Colonization (time frame: Baseline, Day 7, Day 14, and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.