Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients (IGIENE-FAST)

Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study

The aim of this randomized controlled trial is to verify whether the efficacy of perineal hygiene procedures performed in dependent patients admitted to medical or geriatric wards with pre-moistened wipes without water is higher than that found after procedures performed with disposable hand grips, soap, and water.

Study Overview

• Status: Completed
• Conditions: Health Care Associated Infection
• Intervention / Treatment: Procedure: Pre-moistened wipes

Detailed Description

Patients hospitalized in medicine and geriatrics wards will be admitted, both for scheduled and urgent hospitalizations. If the patient meets the study inclusion criteria, we will proceed with the description of the study, the delivery of the information form and the collection of informed consent. Only after signing the consent, the patient can be enrolled in the study. The day following enrollment, the first perineal hygiene in the morning will be performed with pre-moistened wipes without water or with disposable hand grips, soap and water depending on the study group to which the patient has been randomly assigned.

In both groups, a skin swab will be performed before and after the hygiene practice, after which the patient will leave the study.

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS AOU di Bologna
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Reggio Emilia, Italy, 42123
    • Azienda USL-IRCCS di Reggio Emilia
  • Milano
    • Legnano, Milano, Italy, 20025
      • Azienda Ospedaliera, Ospedale Civile di Legnano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years of age inclusive at the time of the study;
• Patients admitted to medical or geriatric wards with scheduled or urgent hospitalization;
• Hypothesis of hospitalization of at least 48 hours
• Totally dependent patients who are bedridden and unable to independently provide for their own personal hygiene.
• Patient-oriented in time and space/cognitively cooperative.
• Acquisition of written informed consent.

Exclusion Criteria:

• Patients who have performed perineal hygiene with wipes or other methods containing antiseptic solutions in the 12-24 hours preceding the execution of the swab for the bacteriological examination.
• Patients who have undergone a treatment procedure in the groin and/or perineal area that required skin antisepsis (e.g. femoral blood sampling, bladder catheter insertion, etc.).
• Patients with known allergies to one of the components of the products used.
• Patients diagnosed with dermatological pathologies.
• Patients colonized or infected with microorganisms transmissible by contact.
• Patients in bowel cleansing preparation for diagnostic procedures e therapeutic.
• Patients with diarrheal bowel.
• Patients hospitalized on Saturdays and Sundays due to the difficulty of illustrating information and acquiring informed consent since healthcare professionals are small in number.
• Patient enrolled and then transferred to another ward or discharged before 48 hours.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water.	Procedure: Pre-moistened wipes; Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
No Intervention: Control group; Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes	The primary objective is to verify whether the effectiveness of perineal hygiene procedures performed in hospitalized dependent patients admitted to medical or geriatric wards using pre-moistened waterless wipes (experimental treatment) is superior to that achieved with standard soap-and-water hygiene. Each participant undergoes one pre-procedure (T0) and one post-procedure (T1) perineal swab for microbiological assessment. According to the prospectively approved study protocol, microbiological success is predefined as achievement of a ≥90% reduction in total viable microbial load (CFU) from baseline (T0) to post-procedure (T1). The primary analysis compares the proportion of participants achieving this predefined endpoint between study groups.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the total costs of the aids used in the two hygiene methods	Cost of materials and personnel	One day
Compare the working times referred to the two hygiene methods	Time expressed in minutes, required for the completion of perineal hygiene for each methodology	One day
Compare the patients' satisfaction with the two hygiene methods	Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)	One day
Compare the approval of health professionals for the two hygiene methods	Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)	One day
Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies	Assessed by a specific ad hoc questionnaire (list of items)	One day

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Azienda Ospedaliera, Ospedale Civile di Legnano; Azienda USL - IRCCS di Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: hygiene
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Cross Infection
• Other Study ID Numbers: IGIENE-FAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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