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Clinical Trials/NCT02640469
NCT02640469WithdrawnNot Applicable

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

NYU Langone Health1 site in 1 countryStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Number of positive cultures in each group

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Chlorhexidine with water rinse (Other)

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.

Intervention: Chlorhexidine without water rinse (Other)

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.

Intervention: Chlorhexidine + sterillium hand rub (Other)

Outcomes

Primary Outcomes

Number of positive cultures in each group

Time Frame: 1 day

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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