Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms

This study is currently recruiting participants.
Verified August 2012 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
Michael Sweet, West Virginia University
ClinicalTrials.gov Identifier:
NCT01671358
First received: August 16, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition
Methicillin-Resistant Staphylococcus Aureus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Contamination Rates of Medication Storage Cabinets Between Isolation and Non-isolation Rooms With Methicillin-resistant Staphylococcus Aureus (MRSA)

Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Presence of MRSA colonization [ Time Frame: Hospital stay, an expected average of 14 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Quantification of MRSA colonization [ Time Frame: Hospital stay, an expected average of 14 days ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Presence of other bacterial colonization [ Time Frame: Hospital stay, an expected average of 14 days ] [ Designated as safety issue: Yes ]
    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.

  • Correlation between MRSA and active infection or colonization of patient [ Time Frame: Hospital stay, an expected average of 14 days ] [ Designated as safety issue: No ]
    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.

  • Correlation between colonization of other positive organisms and active infection or colonization of patient [ Time Frame: Hospital stay, an expected average of 14 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Isolation Rooms for MRSA
Rooms that currently have a patient in them that are in isolation status due to MRSA
Non-isolation rooms
Rooms that have not been occupied by a patient in isolation due to MRSA for 14 days

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inaptients at an academic medical center

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671358

Locations
United States, West Virginia
West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Michael A Sweet, Pharm.D.    304-598-4000 ext 73201    sweetm@wvuhealthcare.com   
Principal Investigator: Michael A Sweet, PharmD         
Sub-Investigator: Holly Kirk, PharmD         
Sub-Investigator: Frank E Briggs, PharmD, MPH         
Sub-Investigator: Rodney B Turner, PharmD         
Sub-Investigator: Rocco LaSala, MD         
Sub-Investigator: Douglas Slain, PharmD         
Sub-Investigator: Rashida Khakoo, MD         
Sponsors and Collaborators
West Virginia University
  More Information

Publications:
Responsible Party: Michael Sweet, Pharmacy Clinical Specialist - Quality Outcomes, West Virginia University
ClinicalTrials.gov Identifier: NCT01671358     History of Changes
Other Study ID Numbers: WVU-00010
Study First Received: August 16, 2012
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
MRSA
Contamination
Isolation

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014