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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06194903
Other study ID # 6015
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date April 1, 2024

Study information

Verified date March 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Patrizia Laurenti, Professor
Phone 06 3015 5278
Email patrizia.laurenti@unicatt.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date April 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
isopropyl alcohol wipes
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 box
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.

Locations

Country Name City State
Italy Fondazione Policlinico Universitario "A. Gemelli" IRCCS Rome

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation.
Secondary 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. Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation
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