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

Overview

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).

Full Title of Study: “Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

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.

Interventions

  • Drug: Chlorhexidine gluconate
    • Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
  • Other: Standard bathing
    • The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Standard bathing
    • Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Nosocomial Infection
    • Time Frame: Up to 28 days
    • Proportion of patients with one or more incident nosocomial infections. 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 Measures

  • Incidence of Skin Irritation
    • Time Frame: up to 28 days
    • 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.
  • ICU Length of Stay in Days
    • Time Frame: up to 28 days
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Joshua Swan
  • Collaborator
    • Texas Southern University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Joshua Swan, Sponsor-Investigator/Principal Investigator – The Methodist Hospital Research Institute
  • Overall Official(s)
    • Joshua T Swan, Pharm.D., Principal Investigator, The Methodist Hospital, Texas Southern University

Citations Reporting on Results

Swan JT, Bui LN, Pham VP, Shirkey BA, Graviss EA, Hai SA, Ashton CM, Wray NP. "RCT of chlorhexidine versus soap & water bathing for prevention of hospital-acquired infections in SICU". Critical Care Medicine. 2014;42(12 supplement):abstract 4.

Swan JT, Ashton CM, Bui LN, Pham VP, Shirkey BA, Blackshear JE, Bersamin JB, Pomer RM, Johnson ML, Magtoto AD, Butler MO, Tran SK, Sanchez LR, Patel JG, Ochoa RA Jr, Hai SA, Denison KI, Graviss EA, Wray NP. Effect of Chlorhexidine Bathing Every Other Day on Prevention of Hospital-Acquired Infections in the Surgical ICU: A Single-Center, Randomized Controlled Trial. Crit Care Med. 2016 Oct;44(10):1822-32. doi: 10.1097/CCM.0000000000001820.

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