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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00971373
First received: September 1, 2009
Last updated: September 2, 2009
Last verified: September 2009
  Purpose

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 ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scrubs
antimicrobial impregnated scrubs
Other: Vestagen scrubs
antimicrobial impregnated textile
Other Names:
  • Vestagen
  • Nanosphere

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT00971373

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

No publications provided

Responsible Party: Gonzalo Bearman, MD MPH- Principle Investigator, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00971373     History of Changes
Other Study ID Numbers: HM12358
Study First Received: September 1, 2009
Last Updated: September 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
antimicrobial
epidemiology
bacteriology
CFU

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014