Skip to main content
OpenTrials
Completed

NCT Number: NCT01640925

Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cross Infection Catheter-Related Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthcare-Associated Pneumonia Iatrogenic Disease Infection Due to Indwelling Urinary Catheter Infections Lung Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Postoperative Complications Respiratory Tract Diseases Respiratory Tract Infections Surgical Wound Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgical Intensive Care Unit, The Methodist Hospital

Houston, Texas, 77030, United States

About this study

Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.

Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
  • Anticipated surgical intensive care unit length of stay of 48 hours or more

Exclusion criteria

  • Pregnancy
  • Age less than 18 years old
  • Braden score of less than 9 upon admission to the surgical intensive care unit
  • Known allergy to chlorhexidine gluconate
  • Active skin irritation upon admission to the surgical intensive care unit

Treatment and study plan

Chlorhexidine gluconate

Drug

Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours

Other names: Bactoshield 4%

Standard bathing

Other

The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Primary outcomes

  1. Incidence of Nosocomial Infection

    Time frame: Up to 28 days

    Proportion of patients with one or more incident nosocomial infections.

    Primary Efficacy Endpoints* (Composite of new nosocomial infection)

    • Primary Bloodstream Infection
    • Catheter Related Urinary Tract Infection
    • Ventilator-Associated Pneumonia**
    • Surgical Site Infection

    (*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints.

    (**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation.

Secondary outcomes

  1. Incidence of Skin Irritation

    Time frame: up to 28 days

    The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.

  2. ICU Length of Stay in Days

    Time frame: up to 28 days

    Number of days in the ICU after enrollment in study until first ICU discharge.

  3. Number of Patients With In-hospital Mortality

    Time frame: up to 28 days or until first hospital discharge

Sponsors and collaborators

Lead sponsor

Joshua Swan

Other

Collaborators

  • Texas Southern University
  • The Methodist Hospital Research Institute

Registry information

Official study title

Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 16, 2012
Registry last updated
Apr 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.