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NCT Number: NCT02033187

Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.

Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).

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Key information

Conditions

Healthcare Associated Infections 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

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center

Exclusion criteria

  • Being cared for in the burn ICU or patients with TEN/SJS or burns being cared for in one of the non-burn intensive care units.
  • Patients with known allergy to chlorhexidine gluconate
  • Age < 18 years old
  • Patients where daily bathing would not be safe

Treatment and study plan

Chlorhexidine bathing

Other

Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit.

Non-chlorhexidine bathing

Other

Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit.

Primary outcomes

  1. A composite of healthcare-associated infections

    Time frame: Daily

    A composite of the following healthcare-associated infections:

    • Central line-associated blood stream infections (CLABSI)
    • Possible or probable ventilator associated pneumonia (VAP)
    • Catheter-associated urinary tract infection (CAUTI)
    • C. difficile-associated diarrhea

Secondary outcomes

  1. Rates of each individual site infection included in the composite calculation above

    Time frame: Daily

    • Central line-associated blood stream infections (CLABSI)
    • Possible or probable ventilator associated pneumonia (VAP)
    • Catheter-associated urinary tract infection (CAUTI)
    • C. difficile-associated diarrhea

  2. Skin reactions

    Time frame: As needed

    Skin reactions related to topical chlorhexidine

  3. Hospital mortality

    Time frame: One year

    Hospital mortality

  4. Hospital length of stay

    Time frame: One year

    Hospital length of stay

  5. ICU length of stay

    Time frame: One year

    ICU length of stay

  6. Rate of cultures positive for multi-drug resistant organisms

    Time frame: Daily

  7. Rates of blood culture contamination

    Time frame: Daily

  8. Rates of healthcare-acquired bloodstream infections

    Time frame: Daily

Other outcomes

  1. Subgroup analysis by the individual intensive care unit

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 10, 2014
Registry last updated
Jan 10, 2014

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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