Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pre-moistened wipes

    Procedure/Surgery

    Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water

Treatment groups

648 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
One day

Secondary outcomes

1

Compare the total costs of the aids used in the two hygiene methods

Cost of materials and personnel

Time frame
One day
2

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
3

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
4

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

Other outcomes

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