MRSA Clinical Trial
Official title:
Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination
| NCT number | NCT03601741 |
| Other study ID # | 17-01633 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 8, 2018 |
| Est. completion date | April 5, 2019 |
| Verified date | September 2019 |
| Source | NYU Langone Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | April 5, 2019 |
| Est. primary completion date | April 5, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Internal Medicine Residents Exclusion Criteria: - NA |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York University School of Medicine | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MRSA colony count cultured from stethoscope diaphragms | 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 | Rate of hospital acquired MRSA infection in patients treated by participating residents | Rates on nosocomial infection in each arm compared through use of Kaplan Meier curves | 14 Days |
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