About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pre-moistened wipes
Procedure/SurgeryPatients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Compare the total costs of the aids used in the two hygiene methods
Cost of materials and personnel
Compare the working times referred to the two hygiene methods
Time expressed in minutes, required for the completion of perineal hygiene for each methodology
Compare the patients' satisfaction with the two hygiene methods
Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)
Compare the approval of health professionals for the two hygiene methods
Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)
Sponsors and contacts
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
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