Alcohol Versus Chlorhexidine With and Without Water

January 5, 2017 updated by: NYU Langone Health

Efficacy of the Use of Alcohol-bases Solutions Versus Chlorhexidine With or Without Water for Hand Sanitation Prior to Surgical Procedure

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

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
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital for Joint Disease

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Chlorhexidine with water rinse

This procedure will be followed for both the right and left hands and arms:

scrub each side of finger, in between fingers and back and front of hands for 2 minutes, followed by scrubbing of arms, keeping hands higher than arms at all times, wash each side of the arms from wrist to elbow for 1 minute
Experimental: 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.
Other: Chlorhexidine without water rinse
Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm.
Active Comparator: 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.
Other: Chlorhexidine + sterillium hand rub
Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. Rinse hands and arms by passing through water in one direction, dry hands, and rub 5 mL of alcohol into the palm of the hands, forearms and elbows. Ensure that the whole skin area on both arms is covered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of positive cultures in each group
Time Frame: 1 day
Evaluated using a Students T-test and analysis of variance (ANOVA).
1 day

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Frank Liporace, MD, NYU Langone Medical Center

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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-00496

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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