Effect of Bed Bathing Methods on VRE Colonization in ICU Patients

NCT07364435 | Completed Results

• 1 other identifier: 2024-188
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vancomycin-Resistant Enterococcus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Device: Disposable antibacterial bed bath wipes

Interventions

Bed Bath PROCEDURE

Daily whole-body bed bathing performed as part of routine ICU care.

Also known as: Daily whole-body bathing with 4% chlorhexidine gluconate solution.

4% Chlorhexidine Gluconate Bed Bath

Disposable antibacterial bed bath wipes DEVICE

Daily whole-body bed bathing using disposable antibacterial body cleansing wipes as part of routine ICU care.

Also known as: Daily bed bathing using disposable antibacterial body cleansing wipes., Antibacterial bathing wipes

Disposable Antibacterial Bed Bath Wipes

Chlorhexidine gluconate 4% DRUG

A 4% chlorhexidine gluconate solution used during the bed bathing procedure for whole-body skin antisepsis in ICU patients.

Also known as: CHG 4% solution

4% Chlorhexidine Gluconate Bed Bath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity to chlorhexidine
• Extensive skin lesions or burns
• Patients colonized or infected with VRE at ICU admission
• Pregnancy

Sponsors & Collaborators

• Özkan Kasap: lead

Study Sites (1)

Basaksehir Pine and Sakura City Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Chromogranins; Solutions

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof.Dr.Ayfer OZBAS
• Organization: Basaksehir Cam and Sakura City Hospital

ayfer.ozbas@demiroglu.bilim.edu.tr

+90 542 232 09 08

Study Officials

• Ayfer Ozbas, Prof.Dr.

  T.C. DEMIROGLU SCIENCE UNIVERSITY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)