Slippers to Reduce Transfer From Floors to Surfaces

June 24, 2021 updated by: Dr. Curtis Donskey, Louis Stokes VA Medical Center

Impact of Wearing Slippers on Transfer of Bacteriophage MS2 From Floors in Patient Rooms to Bedding and Surfaces

The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Subjects are randomized to wear slippers versus standard care and cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces, personal items, bedding, socks or feet, and hands of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Hospitalized patients are enrolled and randomized to wear slippers any time they are out of bed versus standard care. Bacteriophage MS2 is inoculated onto a site on the floor between the patient bed and the bathroom. Cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces (bed rail, bedside table, telephone, call button), personal items, bedding, socks or feet, and hands of patients.

Study Type

Interventional

Enrollment (Actual)

34

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
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland VA Medical Center

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:

  • Adult patients of 18 years of age or older
  • Ambulatory
  • Able to demonstrate an understanding of study procedures

Exclusion Criteria:

  • Unable or unwilling to fulfill study requirements.
  • Expected length of stay less than 48 hours
  • Any patient deemed not suitable for study participation at the discretion of the study investigator

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Slippers
Patients wear slippers any time they are out of bed with a goal of avoiding any contact between socks/feet and the floor
Behavioral: Slippers
Patients in the intervention group wear slippers when out of bed
No Intervention: Control
Patients receive standard care with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands
Time Frame: 48 hours
Cultures for MS2
48 hours

Collaborators and Investigators

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

Sponsor

Louis Stokes VA Medical Center

Investigators

  • Principal Investigator: Curtis J Donskey, MD, Cleveland VA Medical Center

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 (Actual)

August 1, 2020

Primary Completion (Actual)

April 20, 2021

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

June 12, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17044-H34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will provide de-identified individual participant data to those who provide a request in writing.

IPD Sharing Time Frame

Available 6/22/21 through 6/22/24

IPD Sharing Access Criteria

Written request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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