Status:
RECRUITING
Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
Azienda USL - IRCCS di Reggio Emilia
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Health Care Associated Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
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 des...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2024
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT06514131
Start Date
February 20 2024
End Date
December 20 2024
Last Update
July 23 2024
Active Locations (5)
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1
Azienda Ospedaliera, Ospedale Civile di Legnano
Legnano, Milano, Italy, 20025
2
IRCCS AOU di Bologna
Bologna, Italy, 40138
3
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122
4
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42123