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

NCT ID: NCT00971373

Last Updated: 2016-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Exp Scrubs

antimicrobial impregnated scrubs

Group Type EXPERIMENTAL

Vestagen scrubs

Intervention Type OTHER

antimicrobial impregnated textile

Non-antimicrobial scrubs

Non-antimicrobial scrubs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vestagen scrubs

antimicrobial impregnated textile

Intervention Type OTHER

Other Intervention Names

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Vestagen Nanosphere

Eligibility Criteria

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Inclusion Criteria

* HCWs in the MRICU

Exclusion Criteria

* Under the age of 18 who is not a healthcare worker in the MRICU
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gonzalo Bearman, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM12358

Identifier Type: -

Identifier Source: org_study_id

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