Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients

NCT ID: NCT06514131

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2024-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Health Care Associated Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Pre-moistened wipes

Intervention Type PROCEDURE

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pre-moistened wipes

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL - IRCCS di Reggio Emilia

UNKNOWN

Sponsor Role collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role collaborator

Azienda Ospedaliera, Ospedale Civile di Legnano

OTHER

Sponsor Role collaborator

University of Rome Tor Vergata

OTHER

Sponsor Role collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Lea Godino

Principal Investigator - Research Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera, Ospedale Civile di Legnano

Legnano, Milano, Italy

Site Status NOT_YET_RECRUITING

IRCCS AOU di Bologna

Bologna, , Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, , Italy

Site Status NOT_YET_RECRUITING

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, , Italy

Site Status NOT_YET_RECRUITING

University of Rome Tor Vergata

Roma, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Domenica Gazineo

Role: CONTACT

+39 051 214 1317

Facility Contacts

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Annalisa Moscatelli

Role: primary

3482807896

Domenica Gazineo

Role: primary

+39 051 214 1317

Dario La Quintana

Role: primary

0255033107

Monica Guberti

Role: primary

0522295039

Alessandro Sili

Role: primary

0620900164

Other Identifiers

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IGIENE-FAST

Identifier Type: -

Identifier Source: org_study_id

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