Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination

September 12, 2019 updated by: NYU Langone Health

This is a prospective pilot study using a randomized, controlled, single blinded, crossover trial design, evaluating the effect of daily antimicrobial stethoscope diaphragm covers versus uncovered stethoscope. Stethoscopes will be cleaned Sani-cloth germicidal disposable wipes which are effective against MRSA. Each participant will then be randomly assigned to 7 days in either the intervention or the control arm. At the end of the 7 days participants stethoscopes will be cleaned again. This will be followed by another 7 days in the arm that they are not in during the first 7 days.

The primary endpoint is MRSA colony count from stethoscope diaphragms cultures at 7 days, focusing on the difference between the intervention and the control periods. The secondary endpoint is the rate of hospital acquired MRSA infection in patients treated by residents during each period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

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
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Internal Medicine Residents

Exclusion Criteria:

  • NA

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antimicrobial Stethoscope Diaphragm Covers
Other: Daily Antimicrobial Stethoscope Diaphragm Cover
Patients will receive package with instructions to use stethoscope cover, and are then instructed to switch in 7 days
Other: Uncovered Stethoscopes
Patients receive instruction to begin with no covers, and are then instructed to switch in 7 days
Active Comparator: Uncovered Stethoscopes
Other: Daily Antimicrobial Stethoscope Diaphragm Cover
Patients will receive package with instructions to use stethoscope cover, and are then instructed to switch in 7 days
Other: Uncovered Stethoscopes
Patients receive instruction to begin with no covers, and are then instructed to switch in 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRSA colony count cultured from stethoscope diaphragms
Time Frame: 7 Days
Total CFU of each selected pathogen at 7 days compared by paired Mann-Whitney U tests, with each patient serving as their own control
7 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hospital acquired MRSA infection in patients treated by participating residents
Time Frame: 14 Days
Rates on nosocomial infection in each arm compared through use of Kaplan Meier curves
14 Days

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Marwa Moussa, MD, NYU Langone Health

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)

June 8, 2018

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

April 5, 2019

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-01633

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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