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Contamination of Hospital Scrubs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J. Kristie Johnson, University of Maryland
ClinicalTrials.gov Identifier:
NCT01594580
First received: May 7, 2012
Last updated: December 9, 2015
Last verified: December 2015
  Purpose

This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will:

- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering

This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.


Condition Intervention
Bacterial Contamination
Other: Antimicrobial impregnated scrubs
Other: Non-impregnated scrubs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Novel Agent to Decrease Contamination of Hospital Scrubs

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Bacterial contamination of scrubs [ Time Frame: Outcome will be assessed at the end of the hospital shift ( approx 8 hours) ] [ Designated as safety issue: No ]

    Contamination will be defined as:

    • A swab that is determined to be positive for any of Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.


Enrollment: 111
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antimicrobial impregnated scrubs
Those randomized to this arm of the study will wear scrubs impregnated with an antimicrobial.
Other: Antimicrobial impregnated scrubs
Scrubs are impregnated with an antimicrobial product
Placebo Comparator: Non-impregnated scrubs
Those randomized to this arm of the study will wear scrubs not impregnated with an antimicrobial.
Other: Non-impregnated scrubs

Detailed Description:

The outcome of interest is the contamination of scrubs with Staphylococcus aureus, Enterococcus species or Gram-negative bacteria as determined by surface swabs of healthcare worker scrubs after a full 8-hour shift. The outcomes will be analyzed both individually and collectively.

Contamination will be defined as:

- A swab that is determined to be positive for any Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nursing staff engaging in direct patient care
  • Working in select/participating intensive care and intermediate care units
  • Working at least 8 day shifts in one month (study period)

Exclusion Criteria:

  • Pregnant
  • Unable to provide consent
  • Unable to follow study schedule
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594580

Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: J Kristie Johnson, PhD University of Maryland
  More Information

Responsible Party: J. Kristie Johnson, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01594580     History of Changes
Other Study ID Numbers: HP-00051506 
Study First Received: May 7, 2012
Last Updated: December 9, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 29, 2016