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

This study has been completed.
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: September 16, 2014
Last verified: September 2014

July 5, 2012
September 16, 2014
July 2012
May 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01640925 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Randomized Controlled 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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cross Infection
  • Pneumonia, Ventilator-associated
  • Catheter-related Infections
  • Infection Due to Indwelling Urinary Catheter
  • Surgical Wound Infection
  • Drug: Chlorhexidine gluconate
    Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
    Other Name: Bactoshield 4%
  • Other: Standard bathing
    The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
  • 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.
    Intervention: Drug: Chlorhexidine gluconate
  • Placebo Comparator: Standard bathing
    Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
    Intervention: Other: Standard bathing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
September 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01640925
1211-0239
No
The Methodist Hospital System
The Methodist Hospital System
Texas Southern University
Principal Investigator: Joshua T Swan, Pharm.D. The Methodist Hospital, Texas Southern University
The Methodist Hospital System
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP