Clinical trial NCT06514131: Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients
Official title: Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Care Associated Infection
Keywords: hygiene
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Azienda USL - IRCCS di Reggio Emilia
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Azienda Ospedaliera, Ospedale Civile di Legnano
name: University of Rome Tor Vergata
First posted: 2024-07-23
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes
timeFrame: One day
Secondary outcomes:
measure: Compare the total costs of the aids used in the two hygiene methods
timeFrame: One day
measure: Compare the working times referred to the two hygiene methods
timeFrame: One day
measure: Compare the patients' satisfaction with the two hygiene methods
timeFrame: One day
measure: Compare the approval of health professionals for the two hygiene methods
timeFrame: One day
measure: Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies
timeFrame: One day
Other outcomes:
Locations:
city: Legnano
country: Italy
facility: Azienda Ospedaliera, Ospedale Civile di Legnano
state: Milano
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References: