Comparing water and waterless hygiene methods for hospitalized patients
Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study
NA · IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06514131
This study is testing whether using pre-moistened wipes instead of soap and water for cleaning can help keep hospitalized patients healthier by reducing infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 648 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 5 sites (Legnano, Milano and 4 other locations) |
| Trial ID | NCT06514131 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to determine the effectiveness of perineal hygiene procedures using pre-moistened wipes without water compared to traditional methods involving disposable hand grips, soap, and water for totally dependent patients in medical or geriatric wards. Patients will be enrolled after providing informed consent and will undergo hygiene procedures based on their assigned group. Skin swabs will be collected before and after the hygiene practices to assess bacterial presence and efficacy. The study focuses on improving hygiene practices to reduce health care-associated infections in vulnerable hospitalized patients.
Who should consider this trial
Good fit: Ideal candidates are bedridden patients over 18 years old who are totally dependent on caregivers for personal hygiene and are admitted to medical or geriatric wards.
Not a fit: Patients who have undergone recent antiseptic procedures in the perineal area or have specific allergies or dermatological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hygiene practices that reduce the incidence of health care-associated infections in hospitalized patients.
How similar studies have performed: Other studies have explored hygiene practices in healthcare settings, but this specific comparison of water versus waterless methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Legnano, Milano and 4 other locations
- Azienda Ospedaliera, Ospedale Civile di Legnano — Legnano, Milano, Italy (NOT_YET_RECRUITING)
- IRCCS AOU di Bologna — Bologna, Italy (RECRUITING)
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Italy (NOT_YET_RECRUITING)
- Azienda USL-IRCCS di Reggio Emilia — Reggio Emilia, Italy (NOT_YET_RECRUITING)
- University of Rome Tor Vergata — Roma, Italy (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Domenica Gazineo
- Email: domenica.gazineo@aosp.bo.it
- Phone: +39 051 214 1317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Health Care Associated Infection, hygiene