An interventional study of Pre-moistened wipes in Health Care Associated Infection, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Health services research
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.
239 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's enrollment of 468 is above the median of 210 across 142 interventional studies indexed under Cross Infection.
Browse Cross Infection studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water.
Procedure: Pre-moistened wipes
Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water.
Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
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
Assessed by a specific ad hoc questionnaire (list of items)
Time frame: One day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna