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Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500 (JUC)

Primary Purpose

Infectious Disease Transmission

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
JUC solution
propan-2-ol
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Disease Transmission focused on measuring JUC, hand rub, European standard

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy and absence of significant illness

Exclusion Criteria:

  • Visible wounds on hands

Sites / Locations

  • PolyU Biomedical Science Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

JUC solution

Arm Description

Following standard one-minute handwashing, both hands were immersed up to the mid-metacarpals for 5 seconds into a contamination fluid containing E. coli. Handrubs were performed by using 60% propan-2-ol into the cupped hands and rub vigorously for 30 seconds, the procedure was completed by a 5 seconds rinse of the fingers under running tap water and excess water was shaken off.

Following standard one-minute handwashing, both hands were immersed up to the mid-metacarpals for 5 seconds into a contamination fluid containing E. coli. Handrubs were performed by pouring 1.5 ml of JUC into the cupped hands and rub vigorously for 30 seconds, the procedure was completed by a 5 seconds rinse of the fingers under running tap water and excess water was shaken off.

Outcomes

Primary Outcome Measures

Change of Colony forming units on hands from pre-value (baseline) to post-value
Pre-value and post-value were collected by rubbing the fingertips and thumb tips of each hand for 1 minute on the base of a Petri dish containing medium. Then the samples with appropriate dilutions were plated onto agar plates for incubation, and colony forming units of the plates were counted.

Secondary Outcome Measures

Change of colony forming units on hands from baseline to 8 hours after hand rubbing with JUC
JUC was applied after handwashing, an invisible protective frame will be formed on treated hands. Samples were collected for culture each hour after the challenge of the E. coli contamination fluid.Pre-value and post-value were collected by rubbing the fingertips and thumb tips of each hand for 1 minute on the base of a Petri dish containing medium. Then the samples with appropriate dilutions were plated onto agar plates for incubation, and colony forming units of the plates were counted.

Full Information

First Posted
March 22, 2013
Last Updated
December 10, 2014
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01824888
Brief Title
Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500
Acronym
JUC
Official Title
The Effectiveness and Efficacy of Using JUC Antimicrobial Spray for Controlling the Infection Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
JUC is a commercially available wound care spray. It is evaluated for the efficacy when using as a hygienic hand rub following the protocol described in the European standard EN 1500:1997 "Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirement (phase 2/step 2)". A crossover study to compare the JUC solution with 60% (v/v) propan-2-ol by using Escherichia coli K12 NCTC strain 10538 as test organism.
Detailed Description
Before the intervention, the bactericidal activity of JUC was validated in accordance with the prEN 12054. A total of 15 volunteers were recruited, hands were washed immediately prior to the intervention. Then, both hands of each volunteer were immersed into a contamination fluid of E. coli. Then, hand rub was performed with JUC or alcohol. Culture samples were collected before and after the hand rub by rubbing the fingertips and thumb tips of each hand ont he base of a Petri dish containing appropriate medium. The culture inoculation, incubation, appropriate dilutions, and colony count were performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease Transmission
Keywords
JUC, hand rub, European standard

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Following standard one-minute handwashing, both hands were immersed up to the mid-metacarpals for 5 seconds into a contamination fluid containing E. coli. Handrubs were performed by using 60% propan-2-ol into the cupped hands and rub vigorously for 30 seconds, the procedure was completed by a 5 seconds rinse of the fingers under running tap water and excess water was shaken off.
Arm Title
JUC solution
Arm Type
Experimental
Arm Description
Following standard one-minute handwashing, both hands were immersed up to the mid-metacarpals for 5 seconds into a contamination fluid containing E. coli. Handrubs were performed by pouring 1.5 ml of JUC into the cupped hands and rub vigorously for 30 seconds, the procedure was completed by a 5 seconds rinse of the fingers under running tap water and excess water was shaken off.
Intervention Type
Drug
Intervention Name(s)
JUC solution
Other Intervention Name(s)
JUC physical antimicrobial dressing
Intervention Description
1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice
Intervention Type
Drug
Intervention Name(s)
propan-2-ol
Other Intervention Name(s)
alcohol reference
Intervention Description
1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice
Primary Outcome Measure Information:
Title
Change of Colony forming units on hands from pre-value (baseline) to post-value
Description
Pre-value and post-value were collected by rubbing the fingertips and thumb tips of each hand for 1 minute on the base of a Petri dish containing medium. Then the samples with appropriate dilutions were plated onto agar plates for incubation, and colony forming units of the plates were counted.
Time Frame
Pre-value (baseline) as 0 minutes: at the time after handwashing and before application of JUC or alcohol; Post-value at 5 minutes after the baseline: as after hand contamination, application of JUC or alcohol and drying of hands
Secondary Outcome Measure Information:
Title
Change of colony forming units on hands from baseline to 8 hours after hand rubbing with JUC
Description
JUC was applied after handwashing, an invisible protective frame will be formed on treated hands. Samples were collected for culture each hour after the challenge of the E. coli contamination fluid.Pre-value and post-value were collected by rubbing the fingertips and thumb tips of each hand for 1 minute on the base of a Petri dish containing medium. Then the samples with appropriate dilutions were plated onto agar plates for incubation, and colony forming units of the plates were counted.
Time Frame
Pre-value (baseline) at 0 hour: at the first time after applicaiton of JUC and challenged by the bacteria; Post-values measured at each hour (1,2,3,4,5,6,7 and 8 hours) after the initial application of JUC and bacterial challenge at every hour
Other Pre-specified Outcome Measures:
Title
Bactericidal efficacy of JUC and neutralizer
Description
Mixing the JUC with or without neutralizer with a fixed amount of E. coli to assess the bactericidal effects.
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy and absence of significant illness Exclusion Criteria: Visible wounds on hands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Yuen, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PolyU Biomedical Science Laboratory
City
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

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Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500

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