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

Infectious Disease Transmission Clinical Trial

— JUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824888
• Other study ID #: JUC-001-EN1500
• Secondary ID: 8-ZDA4
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2013
• Last updated: December 10, 2014
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• healthy and absence of significant illness

Exclusion Criteria:

• Visible wounds on hands

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease Transmission

Intervention

Drug:
• JUC solution
1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice
• propan-2-ol
1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice

Locations

Country	Name	City	State
Hong Kong	PolyU Biomedical Science Laboratory	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No