Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients

NCT06514131 | Recruiting

• 1 other identifier: IGIENE-FAST
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Health Care Associated Infection

Keywords

hygiene

Outcome Measures

Primary Outcomes (1)

• Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes

  The primary objective is to verify if the effectiveness of the perineal hygiene procedures performed in hospitalized dependent patients in medicine or geriatric wards with pre-moistened wipes without water (experimental treatment) is higher than that found after the procedures performed with soapy disposable grips and water (standard treatment). Each patient will be treated with one of the two methods only once; for each patient, a total of two measurements of microbial load will be performed pre- and post-morning hygiene. Change from baseline in microbial load will be evaluated.

  One day

Secondary Outcomes (5)

• Compare the total costs of the aids used in the two hygiene methods

  One day

• Compare the working times referred to the two hygiene methods

  One day

• Compare the patients' satisfaction with the two hygiene methods

  One day

• Compare the approval of health professionals for the two hygiene methods

  One day

• Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies

  One day

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water.

Procedure: Pre-moistened wipes

Control group

NO INTERVENTION

Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water.

Interventions

Pre-moistened wipes PROCEDURE

Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Azienda USL - IRCCS di Reggio Emilia: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Azienda Ospedaliera, Ospedale Civile di Legnano: collaborator
• University of Rome Tor Vergata: collaborator

Study Sites (5)

Azienda Ospedaliera, Ospedale Civile di Legnano

Legnano, Milano, 20025, Italy

NOT YET RECRUITING

IRCCS AOU di Bologna

Bologna, 40138, Italy

RECRUITING

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

NOT YET RECRUITING

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

NOT YET RECRUITING

University of Rome Tor Vergata

Roma, 00133, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Domenica Gazineo

CONTACT

+39 051 214 1317; domenica.gazineo@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Research Nurse

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: July 23, 2024
• Study Start: February 20, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)