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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640925
First Posted: July 16, 2012
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Texas Southern University
The Methodist Hospital System
Information provided by (Responsible Party):
Joshua Swan, The Methodist Hospital System
  Purpose
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).

Condition Intervention
Cross Infection Pneumonia, Ventilator-associated Catheter-related Infections Infection Due to Indwelling Urinary Catheter Surgical Wound Infection Drug: Chlorhexidine gluconate Other: Standard bathing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Joshua Swan, The Methodist Hospital System:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Blood Culture Contamination Rate [ Time Frame: up to 28 days ]
  • 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.

  • Number of Patients With In-hospital Mortality [ Time Frame: up to 28 days or until first hospital discharge ]

Enrollment: 350
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlorhexidine gluconate bathing
Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
Other Name: Bactoshield 4%
Placebo Comparator: Standard bathing
Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Other: Standard bathing
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640925


Locations
United States, Texas
Surgical Intensive Care Unit, The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Joshua Swan
Texas Southern University
The Methodist Hospital System
Investigators
Principal Investigator: Joshua T Swan, Pharm.D. The Methodist Hospital, Texas Southern University
  More Information

Publications:
Responsible Party: Joshua Swan, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01640925     History of Changes
Other Study ID Numbers: Pro00006876
1211-0239 ( Other Identifier: HMRI IRB )
First Submitted: July 5, 2012
First Posted: July 16, 2012
Results First Submitted: April 15, 2015
Results First Posted: May 22, 2015
Last Update Posted: October 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share data to be determined.

Keywords provided by Joshua Swan, The Methodist Hospital System:
nosocomial infection
hospital acquired infection
chlorhexidine
pneumonia, ventilator-associated
catheter-related infections
urinary tract infections, catheter-related
surgical site infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Wound Infection
Cross Infection
Surgical Wound Infection
Catheter-Related Infections
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Wounds and Injuries
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Postoperative Complications
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents