Randomized Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones (SaniPhone)

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.

Study Overview

• Status: Completed
• Conditions: Cross Infection
• Intervention / Treatment: Device: isopropyl alcohol wipes; Device: UVC box

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cellphones treated with isopropyl alcohol wipes	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.
Experimental: Cellphones treated with UVC box	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: cross infection; UVC; disinfection; cellphone; high touch surfaces; isopropyl alcohol
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: 6015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No