Cross InfectionSaniPhoneNCT06194903
Randomized Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones
A study testing isopropyl alcohol wipes and UVC box in people with Cross Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Cell phones have become a fundamental accessory of our lives and clinical practice, often kept in contact with the body. Since most modern smartphones are equipped with touch screens, they can serve the function of reservoirs for pathogenic microorganisms; moreover, they can be the means of transmission of such… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cross Infection
- What is being tested?
- isopropyl alcohol wipes and UVC box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 1 Apr 2024
- Phase
- Interventional
- 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
- Be a healthcare provider in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
- Own a smartphone
- Carry one's smartphone for the duration of the work shift (8 hours)
- Give consent to participate in the study
- Be willing to report 3 hours after sanitisation for follow-up sampling
Who cannot join
- Not to be a healthcare worker in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
- Not to be on work shift during surveys
- Not to carry one's smartphone for the duration of the work shift (8 hours)
- Not to give consent to participate in the study
- Not to be willing to report 3 hours after sanitisation for follow-up sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Experimental Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones of Healthcare Workers.
Cell phones have become a fundamental accessory of our lives and clinical practice, often kept in contact with the body. Since most modern smartphones are equipped with touch screens, they can serve the function of reservoirs for pathogenic microorganisms; moreover, they can be the means of transmission of such microorganisms from the environment to humans.
A number of observational studies are available in the literature evaluating the effectiveness of various sanitization methods in reducing the bacterial load of high-touch devices, both chemical and physical.
To our knowledge, no real-world evidence is available comparing the residual effect of the two methods on the bacterial load of cell phones, since all available studies are carried out in the laboratory, with inoculums of predetermined bacterial loads whose suppression by the disinfectant is monitored over time, and involve laptops, tablets and keyboards.
- Conditions
- Cross Infection
- Being tested
- isopropyl alcohol wipes, UVC box
- Keywords
- cross infection, high touch surfaces, cellphone, disinfection, isopropyl alcohol, UVC
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isopropyl alcohol wipesDevice
cellphones will be sanitised with isopropyl alcohol wipes and total bacterial load will be assessed immediately before sanitation, immediately after sanitation and 3 hours after sanitation.
UVC boxDevice
cellphones will be sanitised in a UVC box and total bacterial load will be assessed immediately before sanitation, immediately after sanitation and 3 hours after sanitation.
| Study group | Role | What they receive |
|---|---|---|
| Cellphones treated with isopropyl alcohol wipes | Experimental | Not described Receives: Device: isopropyl alcohol wipes |
| Cellphones treated with UVC box | Experimental | Not described Receives: Device: UVC box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total bacterial load at 3 hours after sanitization
The primary objective of the pilot study is to obtain preliminary data on the average total bacterial load at 3 hours after the sanitization intervention (70% isopropyl alcohol wipes or UVC box). These data will allow appropriate sizing of a subsequent trial to evaluate whether, on the cell phones of health care workers at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS, wipes impregnated with 70% isopropyl alcohol are more effective than UVC ray boxes in reducing total bacterial load at 3 hours after sanitization for both isopropyl alcohol wipes and UVC box
Measured: Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation.
Secondary outcomes (1)
Change in the average total bacterial load at 3 hours after sanitization
Explore the change in the average total bacterial load at 3 hours after sanitization interventions compared with the value recorded before sanitisation for both isopropyl alcohol wipes and UVC box.
Measured: Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194903
- Sponsor's protocol ID
- 6015
- Acronym
- SaniPhone
- Status last verified
- Sep 2024
- First submitted
- 22 Dec 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Experimental Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones of Healthcare Workers.
- ClinicalTrials.gov ID
- NCT06194903
- Acronym / sponsor ID
- SaniPhone / 6015
- Conditions
- Cross Infection
- Keywords
- cross infection, high touch surfaces, cellphone, disinfection, isopropyl alcohol, UVC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- 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.
Cell phones have become a fundamental accessory of our lives and clinical practice, often kept in contact with the body. Since most modern smartphones are equipped with touch screens, they can serve the function of reservoirs for pathogenic microorganisms; moreover, they can be the means of transmission of such microorganisms from the environment to humans.
A number of observational studies are available in the literature evaluating the effectiveness of various sanitization methods in reducing the bacterial load of high-touch devices, both chemical and physical.
To our knowledge, no real-world evidence is available comparing the residual effect of the two methods on the bacterial load of cell phones, since all available studies are carried out in the laboratory, with inoculums of predetermined bacterial loads whose suppression by the disinfectant is monitored over time, and involve laptops, tablets and keyboards.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellphones treated with isopropyl alcohol wipes | Experimental | Device: isopropyl alcohol wipes |
| Cellphones treated with UVC box | Experimental | Device: UVC box |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Be a healthcare provider in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
- Own a smartphone
- Carry one's smartphone for the duration of the work shift (8 hours)
- Give consent to participate in the study
- Be willing to report 3 hours after sanitisation for follow-up sampling
Key exclusion criteria (5 listed)
- Not to be a healthcare worker in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
- Not to be on work shift during surveys
- Not to carry one's smartphone for the duration of the work shift (8 hours)
- Not to give consent to participate in the study
- Not to be willing to report 3 hours after sanitisation for follow-up sampling
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 |
|---|---|---|
| isopropyl alcohol wipescellphones will be sanitised with isopropyl alcohol wipes and total bacterial load will be assessed immediately before sanitation, immediately after sanitation and 3 hours after sanitation. | Device | Cellphones treated with isopropyl alcohol wipes |
| UVC boxcellphones will be sanitised in a UVC box and total bacterial load will be assessed immediately before sanitation, immediately after sanitation and 3 hours after sanitation. | Device | Cellphones treated with UVC box |
Primary outcome
Average total bacterial load at 3 hours after sanitization
Time frame: Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation.
The primary objective of the pilot study is to obtain preliminary data on the average total bacterial load at 3 hours after the sanitization intervention (70% isopropyl alcohol wipes or UVC box). These data will allow appropriate sizing of a subsequent trial to evaluate whether, on the cell phones of health care workers at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS, wipes impregnated with 70% isopropyl alcohol are more effective than UVC ray boxes in reducing total bacterial load at 3 hours after sanitization for both isopropyl alcohol wipes and UVC box
1 secondary outcome
Change in the average total bacterial load at 3 hours after sanitization
Time frame: Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation
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 27 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isopropyl alcohol wipes and UVC box in people with Cross Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 5 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 27 Sep 2024. 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 Italy. 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.
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?
Average total bacterial load at 3 hours after sanitization (time frame: Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation.). 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 27 Sep 2024.