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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014