Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Disposable Antibacterial Bed Bath Wipes | Active Comparator | Participants receive daily bed bathing using disposable antibacterial body cleansing wipes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bed Bath | Procedure | Daily whole-body bed bathing performed as part of routine ICU care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 7, Day 14, and Day 21 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ayfer Ozbas, Prof.Dr. | T.C. DEMIROGLU SCIENCE UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basaksehir Pine and Sakura City Hospital | Istanbul | Istanbul | 34000 | Turkey (Türkiye) |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CHG Bathing | Whole-body bathing with 4% chlorhexidine gluconate solution performed daily in ICU patients. |
| FG001 | Disposable Antibacterial Wipes | Daily bed bathing using disposable antibacterial body wipes in ICU patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants were included in the baseline characteristics analysis (CHG bathing: n=105; disposable antibacterial wipes: n=105).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CHG Bathing | Whole-body bathing with 4% chlorhexidine gluconate solution performed daily in ICU patients. |
| BG001 | Disposable Antibacterial Wipes | Daily bed bathing using disposable antibacterial body wipes in ICU patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants at baseline, reported as mean ± standard deviation in years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants with VRE colonization | Baseline, Day 7, Day 14, and Day 21 |
|
Day 1 through Day 21
Adverse events were systematically assessed from Day 1 through Day 21 during the ICU stay and recorded according to the study protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHG Bathing | Whole-body bathing with 4% chlorhexidine gluconate solution performed daily in ICU patients. |
Not provided
Not provided
This study was conducted in a single center intensive care unit setting, which may limit the generalizability of the findings to other institutions and patient populations. In addition, microbiological follow-up was limited to predefined sampling days (baseline, day 7, day 14, and day 21), and potential confounding clinical factors may have influenced VRE colonization outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof.Dr.Ayfer OZBAS | Basaksehir Cam and Sakura City Hospital | +90 542 232 09 08 | ayfer.ozbas@demiroglu.bilim.edu.tr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2026 | Apr 15, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002864 | Chromogranins |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Disposable antibacterial bed bath wipes | Device | Daily whole-body bed bathing using disposable antibacterial body cleansing wipes as part of routine ICU care. |
|
|
| Chlorhexidine gluconate 4% | Drug | A 4% chlorhexidine gluconate solution used during the bed bathing procedure for whole-body skin antisepsis in ICU patients. |
|
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | Disposable Antibacterial Wipes | Daily bed bathing using disposable antibacterial body wipes in ICU patients. | 0 | 105 | 0 | 105 | 0 | 105 |
Not provided
Not provided
Not provided
| D004364 |
| Pharmaceutical Preparations |