Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Information source: The Methodist Hospital System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cross Infection; Pneumonia, Ventilator-associated; Catheter-related Infections; Infection Due to Indwelling Urinary Catheter; Surgical Wound Infection
Intervention: Chlorhexidine gluconate (Drug); Standard bathing (Other)
Phase: N/A
Status: Completed
Sponsored by: The Methodist Hospital System Official(s) and/or principal investigator(s): Joshua T Swan, Pharm.D., Principal Investigator, Affiliation: The Methodist Hospital, Texas Southern University
Summary
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).
Clinical Details
Official title: Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of Nosocomial Infection
Secondary outcome: Incidence of Skin IrritationBlood Culture Contamination Rate ICU Length of Stay in Days Number of Patients With In-hospital Mortality
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Surgical Intensive Care Unit, The Methodist Hospital, Houston, Texas 77030, United States
Additional Information
Starting date: July 2012
Last updated: May 4, 2015
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