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Completed

NCT Number: NCT05485051

Daily Chlorexidine Bath for Health Care Associated Infection Prevention

Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.

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Key information

Conditions

Health Care Associated Infection Catheter-Associated Urinary Tract Infection Central Line-associated Bloodstream Infection (CLABSI) Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina, Colatina, Espírito Santo, Brazil

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About this study

Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients ≥ 18 years/old admitted to the participants's ICUs

Exclusion criteria

  • History of chlorhexidine allergy

Treatment and study plan

2% chlorhexidine digluconate solution with surface-active agents

Other

Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.

Other names: Chlorhexidine baths

Usual Baths

Other

Bathing will be performed at least daily using soap and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.

Other names: Soap and water baths

Primary outcomes

  1. Composite of healthcare-associated infections (HAI)

    Time frame: Within each cluster duration (90 days)

    Composite outcome of the following HAI:

    Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)

Secondary outcomes

  1. Rates of multi-drug-resistant pathogens

    Time frame: Within each cluster duration (90 days)

    Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.

  2. Ventilator associated pneumonia (VAP)

    Time frame: Within each cluster duration (90 days)

    Rates of Ventilator associated pneumonia (VAP)

  3. Central line-associated blood stream infections (CLABSI)

    Time frame: Within each cluster duration (90 days)

    Rates of Central line-associated blood stream infections (CLABSI)

  4. Catheter-associated urinary tract infection (CAUTI)

    Time frame: Within each cluster duration (90 days)

    Rates of Catheter-associated urinary tract infection (CAUTI)

  5. Hospital length of stay

    Time frame: Until hospital discharge, maximum 90 days

    Hospital length of stay

  6. Intensive Care Unit length of stay

    Time frame: Until Intensive Care Unit discharge, maximum 90 days

    Intensive Care Unit length of stay

  7. Antibiotic use

    Time frame: Within each cluster duration (90 days)

    Antibiotic use per unit

  8. In hospital mortality

    Time frame: Maximum 90 days after randomization

    In hospital mortality

  9. Intensive Care Unit mortality

    Time frame: Maximum 90 days after randomization

    Intensive Care Unit mortality

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Beneficência Portuguesa de São Paulo
  • Hospital Alemão Oswaldo Cruz
  • Hospital Israelita Albert Einstein
  • Hospital Moinhos de Vento
  • Hospital Sirio-Libanes

Registry information

Official study title

Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial

Acronym: CLEAN-IT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2022
Registry last updated
Jun 13, 2024

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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