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

The Effectiveness and Efficacy of Using JUC Antimicrobial Spray for Controlling the Infection Transmission

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease Transmission
• Intervention / Treatment: Drug: propan-2-ol; Drug: JUC solution

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • PolyU Biomedical Science Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy and absence of significant illness

Exclusion Criteria:

• Visible wounds on hands

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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.	Drug: propan-2-ol; 1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice; Other Names: alcohol reference
Experimental: JUC solution; 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.	Drug: JUC solution; 1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice; Other Names: JUC physical antimicrobial dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bactericidal efficacy of JUC and neutralizer	Mixing the JUC with or without neutralizer with a fixed amount of E. coli to assess the bactericidal effects.	1 day

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: JUC; hand rub; European standard
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: JUC-001-EN1500; 8-ZDA4 (Other Grant/Funding Number: PolyU-Grant-8-ZDA4)