NCT02640469

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

December 16, 2015

Last Update Submit

January 5, 2017

Conditions

Keywords

chlorhexidinesterilitysterile hands

Outcome Measures

Primary Outcomes (1)

  • Number of positive cultures in each group

    Evaluated using a Students T-test and analysis of variance (ANOVA).

    1 day

Study Arms (3)

Chlorhexidine with water rinse

ACTIVE COMPARATOR

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

Chlorhexidine without water rinse

EXPERIMENTAL

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

Chlorhexidine + sterillium hand rub

ACTIVE COMPARATOR

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

Interventions

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 with 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.

Chlorhexidine without water rinse

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.

Chlorhexidine + sterillium hand rub

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Hospital for Joint Disease

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

InfectionsInfertility

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Frank Liporace, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 29, 2015

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations