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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

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE June 8, 2018
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination
Official Title  ICMJE Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE MRSA
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Antimicrobial Stethoscope Diaphragm Covers
    Interventions:
    • Other: Daily Antimicrobial Stethoscope Diaphragm Cover
    • Other: Uncovered Stethoscopes
  • Active Comparator: Uncovered Stethoscopes
    Interventions:
    • Other: Daily Antimicrobial Stethoscope Diaphragm Cover
    • Other: Uncovered Stethoscopes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
36
Actual Study Completion Date  ICMJE April 5, 2019
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Internal Medicine Residents

Exclusion Criteria:

  • NA
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03601741
Other Study ID Numbers  ICMJE 17-01633
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marwa Moussa, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP