Pre-moistened wipes
ProcedurePatients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
NCT Number: NCT06514131
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Azienda Ospedaliera, Ospedale Civile di Legnano, Legnano, Milano, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
Time frame: One day
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
Cost of materials and personnel
Time frame: One day
Time expressed in minutes, required for the completion of perineal hygiene for each methodology
Time frame: One day
Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)
Time frame: One day
Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)
Time frame: One day
Assessed by a specific ad hoc questionnaire (list of items)
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study
Acronym: IGIENE-FAST
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