Enhanced Room Cleaning in Intensive Care Units to Reduce Gown and Glove Contamination With Multi-drug-resistant Bacteria

February 15, 2022 updated by: Anthony Harris, University of Maryland, Baltimore

Use of an Enhanced Room Cleaning Protocol in the Intensive Care Unit to Reduce Contamination of Disposable Isolation Gowns and Gloves With Methicillin-resistant Staphylococcus Aureus and Multi-drug Resistant Acinetobacter Baumannii

The purpose of this study is to determine whether extra cleaning of frequently-contaminated surfaces in intensive care rooms is effective in preventing contamination of disposable isolation gowns and gloves with multi-drug resistant bacteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hospital infections are often caused by bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multi-drug-resistant Acinetobacter baumannii (MDRAB). Hospital infections increase the cost of health care, length of hospital stay, and mortality compared to infections with antibiotic-susceptible organisms. Many of these antibiotic-resistant bacteria are transmitted by patient-to-patient contact.

Healthcare workers are one possible vector of patient-to-patient transmission. Transient colonization of hands, clothing and protective equipment can leads to the colonization and infection of other patients. The surfaces of patient rooms are also frequently contaminated with antibiotic-resistant bacteria. A number of recent studies have concluded that patient rooms are not cleaned thoroughly or frequently enough to keep commonly touched surfaces free of bacterial contamination. Given the frequency of contact between the healthcare worker and the patient's environment, bacteria that contaminate environmental surfaces while the patient is in the room are a significant potential reservoir for patient-to-patient transmission via the hands of healthcare workers.

In this study, the investigators will examine rooms of intensive care unit patients colonized with MRSA or MDRAB. The investigators will randomize these rooms to receive either standard room cleaning plus a cleaning of high-touch surfaces ('enhanced cleaning') or to receive only standard room cleaning plus a sham cleaning of high-touch surfaces ('sham enhanced cleaning'). The investigators will then culture healthcare workers' disposable isolation gowns and gloves as they exit the enrolled room after routine patient care activities. The investigators will examine the cultures for the presence of MRSA or MDRAB to determine whether additional cleaning significantly reduces the proportion of healthcare workers with contaminated gloves and gowns, and therefore may reduce the risk of transmitting these bacteria to other patients. The results of this trial will help guide future efforts to decrease patient-to-patient transmission of antibiotic-resistant bacteria.

Study Type

Interventional

Enrollment (Actual)

190

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
    • Maryland
      • Baltimore, Maryland, United States, 21230
        • University of Maryland, Baltimore

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:

  • Room is occupied by a patient colonized with methicillin-resistant Staphylococcus aureus and/or multi-drug-resistant Acinetobacter baumannii
  • Occupant of the room is on contact precautions
  • Occupant was admitted to the room at least 24 hours prior to the time of screening

Exclusion Criteria:

  • Room is occupied by a patient who occupied another room at the time it was enrolled and followed.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Cleaning
Rooms in the Enhanced Cleaning arm will receive cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff.
Other: Enhanced cleaning of surfaces in ICU rooms
Using a paper towel pre-soaked with a commercially-available quaternary ammonium cleaning solution (Virex WetTask wipes, Kimberly-Clark, Irving, Texas), the following surfaces will be wiped clean by a study investigator if present: bed rail top bar, bed electronic control surfaces, moveable tray table top and control surfaces desktop and sides, IV poles, infusion pump control surfaces, nurse call button, patient telephone/remote control, sink console top, light switches and plates, supply cart top and drawer handles, ventilator control surfaces and desk, vital signs monitor control surfaces. Cleaning will occur once on the day of enrollment and follow-up.
Other Names:
  • Environmental cleaning
Sham Comparator: Sham Enhanced Cleaning
Rooms in the Sham Enhanced Cleaning arm will receive a sham cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff.
Other: Sham enhanced cleaning of surfaces in ICU rooms
While holding a paper towel pre-soaked with a commercially-available quaternary ammonium cleaning solution (Virex WetTask wipes, Kimberly-Clark, Irving, Texas), a study investigator will mime the action of wiping the following surfaces in the room clean if present: bed rail top bar, bed electronic control surfaces, moveable tray table top and control surfaces desktop and sides, IV poles, infusion pump control surfaces, nurse call button, patient telephone/remote control, sink console top, light switches and plates, supply cart top and drawer handles, ventilator control surfaces and desk, vital signs monitor control surfaces. The sham cleaning will occur once on the day of enrollment and follow-up.
Other Names:
  • Sham Environmental Cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii
Time Frame: As a healthcare worker exits the enrolled room (1 day)
Swabs will be collected from the disposable gown and gloves of healthcare workers exiting the enrolled room. A single swab will be used for both gloves and the gown. The swab will be assayed for methicillin-resistant Staphylococcus aureus, multi-drug-resistant Acinetobacter baumannii, or both, depending on which organism(s) the occupant of the enrolled room is colonized with. The swab will be considered positive if the relevant organism is isolated. We will sample the first 15 healthcare worker exits after the room has received the allocated intervention.
As a healthcare worker exits the enrolled room (1 day)

Collaborators and Investigators

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

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Anthony D Harris, MD MPH, University of Maryland, Baltimore

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

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00048554

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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