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

March 27, 2018 updated by: Joshua Swan

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Surgical Intensive Care Unit, The Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 28 days
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.
up to 28 days
Number of Patients With In-hospital Mortality
Time Frame: up to 28 days or until first hospital discharge
up to 28 days or until first hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua Swan

Collaborators

The Methodist Hospital Research Institute
Texas Southern University

Investigators

  • Principal Investigator: Joshua T Swan, Pharm.D., The Methodist Hospital, Texas Southern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00006876
  • 1211-0239 (Other Identifier: HMRI IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plan to share data to be determined.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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