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CompletedNCT03639363DuclorexintUpdated Aug 21, 2018

4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings

A Phase 4 interventional study of 4% chlorhexidine gluconate soap-like solution and standard soap in Hospital Infection, sponsored by University Of Perugia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by University Of Perugia · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Aug 2015, registered Aug 2018).
Phase
Phase 4
Study type
Interventional
Enrollment
449
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.

02

Conditions studied

  • Hospital Infection

Keywords

  • 4% chlorhexidine gluconate
  • infection control
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 449 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Of Perugia is the lead sponsor of 51 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU)
  • ICU/PC-ICU stay for at least 1 night

Exclusion criteria

Exclusion Criteria:

  • known allergy to chlorhexidine
  • burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
  • pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
449 participants (actual)

Study arms

  • Experimental
    Intervention Arm

    daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing

    Drug: 4% chlorhexidine gluconate soap-like solution

  • Active comparator
    Control Arm

    daily bathing with standard soap

    Other: standard soap

Interventions

  • Drug4% chlorhexidine gluconate soap-like solution

    1. humidify the whole body surface with the exception of the face using water-impregnated washcloths 2. use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG 3. wait for at least 30 seconds 4. rinse using water-impregnated washcloths

  • Otherstandard soap

    1. humidify the whole body surface with the exception of the face using water-impregnated washcloths 2. use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face 3. wait for at least 30 seconds 4. rinse using water-impregnated washcloths

06

What researchers measure

Primary outcomes

  1. hospital acquired infections incidence

    cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)

    Time frame: infections occured 48 hours after admission to ICU/PC-ICU

Secondary outcomes

  1. Ventilator-associated pnemonias (VAP) incidence

    VAP incidence

    Time frame: infections occured 48 hours after admission to ICU/PC-ICU

  2. Bloodstream infections (BSI) incidence

    BSI incidence

    Time frame: infections occured 48 hours after admission to ICU/PC-ICU

  3. central-line associated BSI (CLABSI) incidence

    CLABSI incidence

    Time frame: infections occured 48 hours after admission to ICU/PC-ICU

  4. urinary tract infections (UTI) incidence

    UTI incidence

    Time frame: infections occured 48 hours after admission to ICU/PC-ICU

  5. catheter associated UTI (CAUTI) incidence

    CAUTI incidence

    Time frame: infections occured 48 hours after admission to ICU/PC-ICU

  6. 4% CHG daily bathing safety

    overall mortality in the treatment and control arm

    Time frame: at discharge, approximately up to 10 days

  7. 4% CHG daily bathing-related adverse events

    4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events

    Time frame: at discharge, approximately up to 10 days

  8. time till infection

    time between admission to ICU/PC-ICU and infection occurrence

    Time frame: at discharge, approximately up to 10 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26. PubMed 30267930 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 27, 2015

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03639363
Lead sponsor
University Of Perugia
Collaborators
Fondazione Toscana Gabriele Monasterio
Responsible party
Carlo Pallotto (Medical Doctor, Principal investigator, University Of Perugia) — Principal investigator
First posted
Aug 21, 2018
Start date
Aug 10, 2015
Primary completion
Apr 28, 2016
Completion
May 2, 2016
Last update
Aug 21, 2018

Study contacts

franco baldelli, Professor
study chair · Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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