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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
468
Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
Azienda Ospedaliera, Ospedale Civile di Legnano
Legnano, Milano, Italy
IRCCS AOU di Bologna
Bologna, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, Italy
Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes
The primary objective is to verify whether the effectiveness of perineal hygiene procedures performed in hospitalized dependent patients admitted to medical or geriatric wards using pre-moistened waterless wipes (experimental treatment) is superior to that achieved with standard soap-and-water hygiene. Each participant undergoes one pre-procedure (T0) and one post-procedure (T1) perineal swab for microbiological assessment. According to the prospectively approved study protocol, microbiological success is predefined as achievement of a ≥90% reduction in total viable microbial load (CFU) from baseline (T0) to post-procedure (T1). The primary analysis compares the proportion of participants achieving this predefined endpoint between study groups.
Time frame: One day
Compare the total costs of the aids used in the two hygiene methods
Cost of materials and personnel
Time frame: One day
Compare the working times referred to the two hygiene methods
Time expressed in minutes, required for the completion of perineal hygiene for each methodology
Time frame: One day
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)
Time frame: One day
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)
Time frame: One day
Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies
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Assessed by a specific ad hoc questionnaire (list of items)
Time frame: One day