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OpenTrials
Completed

NCT Number: NCT06514131

Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera, Ospedale Civile di Legnano, Legnano, Milano, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient-oriented in time and space/cognitively cooperative.
  • Acquisition of written informed consent.

Exclusion criteria

  • 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.
  • Patients colonized or infected with microorganisms transmissible by contact.
  • Patients in bowel cleansing preparation for diagnostic procedures e therapeutic.
  • Patients with diarrheal bowel.
  • Patients hospitalized on Saturdays and Sundays due to the difficulty of illustrating information and acquiring informed consent since healthcare professionals are small in number.
  • Patient enrolled and then transferred to another ward or discharged before 48 hours.

Treatment and study plan

Pre-moistened wipes

Procedure

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

Primary outcomes

  1. Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes

    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.

Secondary outcomes

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

    Time frame: One day

    Cost of materials and personnel

  2. Compare the working times referred to the two hygiene methods

    Time frame: One day

    Time expressed in minutes, required for the completion of perineal hygiene for each methodology

  3. Compare the patients' satisfaction with the two hygiene methods

    Time frame: One day

    Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)

  4. Compare the approval of health professionals for the two hygiene methods

    Time frame: One day

    Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome)

  5. Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies

    Time frame: One day

    Assessed by a specific ad hoc questionnaire (list of items)

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • Azienda Ospedaliera, Ospedale Civile di Legnano
  • Azienda USL - IRCCS di Reggio Emilia
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Registry information

Official study title

Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study

Acronym: IGIENE-FAST

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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