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Pilot Study to Determine the Effectiveness of Antimicrobial Healthcare Worker's (HCW) Hands and Clothing

This study has been completed.
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: September 1, 2009
Last updated: June 6, 2016
Last verified: June 2016
This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial burden of HCW's hands and clothing in a clinical setting.

Condition Intervention
Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting
Other: Vestagen scrubs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Pilot Study to Determine the Effectiveness of Antimicrobial Scrubs on Bacterial Burden of HCW's Hands and Clothing in a Clinical Setting

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Effectiveness of Antimicrobial impregnated scrubs [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HCW hand and scrub average bacterial counts [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exp Scrubs
antimicrobial impregnated scrubs
Other: Vestagen scrubs
antimicrobial impregnated textile
Other Names:
  • Vestagen
  • Nanosphere
No Intervention: Non-antimicrobial scrubs
Non-antimicrobial scrubs

Detailed Description:

Goals of the pilot study:

  • Compare CFU counts on antimicrobial vs standard scrubs in a clinical setting
  • Assess CFU counts on the hands of HCWs wearing antimicrobial vs non-antimicrobial scrubs
  • Assess HCW hand hygiene compliance during the study protocol
  • Correlate device associated infection rates during protocol to historical controls
  • Assess feasibility of applying protocol to a longer,12-24 month, prospective crossover-trial to definitively study and assess the impact of antimicrobial scrubs on HCW apparel and hand colonization, control of multi-drug resistance organisms, hand hygiene compliance, and device associated hospital acquired infection rates.

II. Design

Cross-over trial in an ICU or Hospital Ward

III. Outcome Measures

  1. CFU count on participants

    1. Hands
    2. Scrubs
    3. Antimicrobial scrubs vs standard scrubs
  2. Hand Hygiene Compliance
  3. Device associated nosocomial infections rates

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

Inclusion Criteria:

  • HCWs in the MRICU

Exclusion Criteria:

  • Under the age of 18 who is not a healthcare worker in the MRICU
  Contacts and Locations
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Please refer to this study by its identifier: NCT00971373

United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Gonzalo Bearman, M.D., MPH Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University Identifier: NCT00971373     History of Changes
Other Study ID Numbers: HM12358 
Study First Received: September 1, 2009
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Additional relevant MeSH terms:
Anti-Infective Agents processed this record on October 21, 2016