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Completed

NCT Number: NCT03639363

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

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.

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Key information

Conditions

Hospital Infection Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

4% chlorhexidine gluconate soap-like solution

Drug
  • humidify the whole body surface with the exception of the face using water-impregnated washcloths
  • 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
  • wait for at least 30 seconds
  • rinse using water-impregnated washcloths

standard soap

Other
  • humidify the whole body surface with the exception of the face using water-impregnated washcloths
  • use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face
  • wait for at least 30 seconds
  • rinse using water-impregnated washcloths

Primary outcomes

  1. hospital acquired infections incidence

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

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

Secondary outcomes

  1. Ventilator-associated pnemonias (VAP) incidence

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

    VAP incidence

  2. Bloodstream infections (BSI) incidence

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

    BSI incidence

  3. central-line associated BSI (CLABSI) incidence

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

    CLABSI incidence

  4. urinary tract infections (UTI) incidence

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

    UTI incidence

  5. catheter associated UTI (CAUTI) incidence

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

    CAUTI incidence

  6. 4% CHG daily bathing safety

    Time frame: at discharge, approximately up to 10 days

    overall mortality in the treatment and control arm

  7. 4% CHG daily bathing-related adverse events

    Time frame: at discharge, approximately up to 10 days

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

  8. time till infection

    Time frame: at discharge, approximately up to 10 days

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

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Collaborators

  • Fondazione Toscana Gabriele Monasterio

Registry information

Official study title

Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units

Acronym: Duclorexint

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2018
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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