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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 Irritation

Blood 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

Page last updated: August 23, 2015

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