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

June 6, 2016 updated by: Virginia Commonwealth University

Pilot Study to Determine the Effectiveness of Antimicrobial Scrubs on Bacterial Burden of HCW's Hands and Clothing in a Clinical Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HCWs in the MRICU

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exp Scrubs
antimicrobial impregnated scrubs
Other: Vestagen scrubs
antimicrobial impregnated textile
Other Names:
  • Vestagen
  • Nanosphere
No Intervention: Non-antimicrobial scrubs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness of Antimicrobial impregnated scrubs
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HCW hand and scrub average bacterial counts
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Gonzalo Bearman, M.D., MPH, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM12358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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