Infectious Disease TransmissionPhase 2JUCNCT01824888
Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500
A Phase 2 study testing JUC solution and propan-2-ol in people with Infectious Disease Transmission, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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)". Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease Transmission
- What is being tested?
- JUC solution and propan-2-ol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2012to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy and absence of significant illness
Who cannot join
- Visible wounds on hands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infectious Disease Transmission
- Being tested
- JUC solution, propan-2-ol
- Keywords
- JUC, hand rub, European standard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUC solutionDrug
Also called JUC physical antimicrobial dressing
1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice
propan-2-olDrug
Also called alcohol reference
1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Drug: propan-2-ol |
| JUC solution | Experimental | 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. Receives: Drug: JUC solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Disease TransmissionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Yuen, The Hong Kong Polytechnic University
- Investigators
- John Yuen, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824888
- Sponsor's protocol ID
- JUC-001-EN1500
- Other IDs
- 8-ZDA4
- Acronym
- JUC
- Status last verified
- Dec 2014
- First submitted
- 22 Mar 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Efficacy of Using JUC Antimicrobial Spray for Controlling the Infection Transmission
- ClinicalTrials.gov ID
- NCT01824888
- Acronym / sponsor ID
- JUC / JUC-001-EN1500
- Conditions
- Infectious Disease Transmission
- Keywords
- JUC, hand rub, European standard
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: propan-2-olFollowing 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. |
| JUC solution | Experimental | Drug: JUC solutionFollowing 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy and absence of significant illness
Key exclusion criteria (1 listed)
- Visible wounds on hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUC solutionAlso: JUC physical antimicrobial dressing1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice | Drug | JUC solution |
| propan-2-olAlso: alcohol reference1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice | Drug | Control |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
Related trials for Infectious Disease Transmission
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Yuen, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JUC solution and propan-2-ol in people with Infectious Disease Transmission, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.