Completed

NCT Number: NCT01824888

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

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.

Completed

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Key information

Conditions

Infectious Disease Transmission

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PolyU Biomedical Science Laboratory

Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy and absence of significant illness

Exclusion criteria

Visible wounds on hands

Treatment and study plan

JUC solution

Drug

1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice

Other names: JUC physical antimicrobial dressing

propan-2-ol

Drug

1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice

Other names: alcohol reference

Primary outcomes

Change of Colony forming units on hands from pre-value (baseline) to post-value

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

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 outcomes

Change of colony forming units on hands from baseline to 8 hours after hand rubbing with JUC

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

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.

Other outcomes

Bactericidal efficacy of JUC and neutralizer

Time frame: 1 day

Mixing the JUC with or without neutralizer with a fixed amount of E. coli to assess the bactericidal effects.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Acronym: JUC

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Apr 5, 2013
Registry last updated: Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.