Alcohol Versus Chlorhexidine With and Without Water

Not Applicable

Withdrawn

• Conditions: Infection
• Interventions: Other: Chlorhexidine + sterillium hand rub; Other: Chlorhexidine with water rinse; Other: Chlorhexidine without water rinse

• Registration Number: NCT02640469
• Lead Sponsor: NYU Langone Health

Brief Summary

Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.

Detailed Description

No current recommendations exist advocating the use of Providine-iodine or Chlorhexidine. Providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. Chlorhexidine similarly disrupts cellular membranes. It is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts.

All subjects who are employees of the NYU Hospital for Joint Diseases and have experience with surgical hand disinfection will be asked to enroll. Subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. After hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Study Start: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-09
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Orthopedic resident or surgical employee of NY U
• Over 21 years of age
• Procedural knowledge of correct aseptic scrub technique

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Exclusion Criteria

• No surgical experience
• Under 21 years of age
• Refusal to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine + sterillium hand rub	Chlorhexidine + sterillium hand rub	This is a standard method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing.
Chlorhexidine with water rinse	Chlorhexidine with water rinse	This is a traditional method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing.
Chlorhexidine without water rinse	Chlorhexidine without water rinse	This is an experimental method of disinfection. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing.

Primary Outcome Measures

Name	Time	Method
Number of positive cultures in each group	1 day	Evaluated using a Students T-test and analysis of variance (ANOVA).

Trial Locations

Locations (1)

New York University Hospital for Joint Disease; 🇺🇸 New York, New York, United States