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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Texas Southern University
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01640925
First received: July 5, 2012
Last updated: July 10, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 The Methodist Hospital System:

Primary Outcome Measures:
  • Incidence of nosocomial infection [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • ICU length of stay in days [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640925

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

No publications provided

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01640925     History of Changes
Other Study ID Numbers: 1211-0239
Study First Received: July 5, 2012
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Cross Infection
Pneumonia
Surgical Wound Infection
Wound Infection
Catheter-Related Infections
Pneumonia, Ventilator-Associated
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014