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CompletedNCT00971373Updated Jun 8, 2016

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

An interventional study of Vestagen scrubs in Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-08.

Sponsored by Virginia Commonwealth University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting

Keywords

  • antimicrobial
  • epidemiology
  • bacteriology
  • CFU
03

In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • HCWs in the MRICU

Exclusion criteria

Exclusion Criteria:

  • Under the age of 18 who is not a healthcare worker in the MRICU
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Exp Scrubs

    antimicrobial impregnated scrubs

    Other: Vestagen scrubs

  • No intervention
    Non-antimicrobial scrubs

    Non-antimicrobial scrubs

Interventions

  • OtherVestagen scrubs

    antimicrobial impregnated textile

    Also known as: Vestagen, Nanosphere

06

What researchers measure

Primary outcomes

  1. Effectiveness of Antimicrobial impregnated scrubs

    Time frame: 4 months

Secondary outcomes

  1. HCW hand and scrub average bacterial counts

    Time frame: 4 months

07

Study locations

1 site
  • Virginia Commonwealth University Medical Center
    Richmond, Virginia 23219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00971373
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Sep 3, 2009
Start date
Sep 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Jun 8, 2016

Study contacts

Gonzalo Bearman, M.D., MPH
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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