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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01671358
Other study ID # WVU-00010
Secondary ID
Status Completed
Phase N/A
First received August 16, 2012
Last updated June 1, 2015
Start date August 2012
Est. completion date June 2013

Study information

Verified date June 2015
Source West Virginia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them.


Description:

Studies show high touch areas maybe contaminated with organisms such as Methicillin—resistant Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at higher risk for developing a hospital-acquired infection.

This study is to determine if medication cabinets located outside of MRSA isolation rooms and their contents, particularly medications and the pharmacy delivery folders are at a higher risk of having MRSA colonization on them. This study will use conventional methods to determine if MRSA colonization is present and compare results between non-isolation and isolation rooms. This will evaluate if alternate measures for the reduction of MRSA colonization are needed for the MRSA isolation rooms in regards to medication delivery and storage.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient rooms with isolation status for MRSA

- Patient rooms without isolation status for MRSA for 14 days

Exclusion Criteria:

- Rooms without medication cabinets directly outside the room

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States West Virginia University Hospitals Morgantown West Virginia

Sponsors (1)

Lead Sponsor Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bures S, Fishbain JT, Uyehara CF, Parker JM, Berg BW. Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000 Dec;28(6):465-71. — View Citation

Huang R, Mehta S, Weed D, Price CS. Methicillin-resistant Staphylococcus aureus survival on hospital fomites. Infect Control Hosp Epidemiol. 2006 Nov;27(11):1267-9. Epub 2006 Sep 28. — View Citation

Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. — View Citation

Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin-sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun;51(2):140-3. — View Citation

Sexton T, Clarke P, O'Neill E, Dillane T, Humphreys H. Environmental reservoirs of methicillin-resistant Staphylococcus aureus in isolation rooms: correlation with patient isolates and implications for hospital hygiene. J Hosp Infect. 2006 Feb;62(2):187-94. Epub 2005 Nov 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Presence of other bacterial colonization Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will be categorized as gram negative, gram positive catalase negative, Gram positive coagulase negative Staphylococcus species or methicillin-sensitive Staphylococcus aureus. This will serve as a baseline epidemiology of the hospital and generate other possible hypotheses. Hospital stay, an expected average of 14 days Yes
Other Correlation between MRSA and active infection or colonization of patient The patient from the same time frame in the rooms sampled and positive for MRSA colonization will be reviewed to determine if they had active infection or were previously colonized. Hospital stay, an expected average of 14 days No
Other Correlation between colonization of other positive organisms and active infection or colonization of patient The patient from the same time frame in the rooms sampled and positive for non-MRSA colonization will be reviewed to determine if they had active infection or were previously colonized. Hospital stay, an expected average of 14 days No
Primary Presence of MRSA colonization Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will then be run through standard identification tests to determine if the colonies are MRSA or not. A comparison will be made between non-isolation and isolation rooms. Hospital stay, an expected average of 14 days Yes
Secondary Quantification of MRSA colonization Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. A comparison between the sites of swabbing will be performed. Hospital stay, an expected average of 14 days Yes
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