Alcohol Versus Chlorhexidine With and Without Water

NCT ID: NCT02640469

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-01-31

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

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine with water rinse

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Chlorhexidine without water rinse

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine + sterillium hand rub

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Liporace, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

New York University Hospital for Joint Disease

New York, New York, United States

Countries

United States

Other Identifiers

14-00496

Identifier Type: -

Identifier Source: org_study_id