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Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination

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ClinicalTrials.gov Identifier: NCT03601741
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
MRSA Other: Daily Antimicrobial Stethoscope Diaphragm Cover Other: Uncovered Stethoscopes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Internal Medicine Residents

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601741


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Marwa Moussa, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03601741    
Other Study ID Numbers: 17-01633
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents