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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 3, 2009
Last Update Posted: June 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
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 (Participant)
Official Title: Pilot Study to Determine the Effectiveness of Antimicrobial Scrubs on Bacterial Burden of HCW's Hands and Clothing in a Clinical Setting

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Effectiveness of Antimicrobial impregnated scrubs [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • HCW hand and scrub average bacterial counts [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00971373     History of Changes
Other Study ID Numbers: HM12358
First Submitted: September 1, 2009
First Posted: September 3, 2009
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Virginia Commonwealth University:

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents