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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infectious Disease Transmission

Intervention / Treatment
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* Drug: JUC solution
* Drug: propan-2-ol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy and absence of significant illness Exclusion Criteria: Visible wounds on hands
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* 1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice<br>* Other names: alcohol reference;|
| Experimental: JUC solution<br>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<br>* 1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice<br>* Other names: JUC physical antimicrobial dressing;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JUC, hand rub, European standard