Health Care Associated InfectionIGIENE-FASTNCT06514131
Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients
A study testing Pre-moistened wipes in people with Health Care Associated Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Associated Infection
- What is being tested?
- Pre-moistened wipes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 4 sitesItaly
- Study dates
- 20 Feb 2024to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
IRCCS AOU di Bologna
Bologna, 40138
Azienda Ospedaliera, Ospedale Civile di Legnano
Legnano, Milano, 20025
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, 42123
About this study
Official title: Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Health Care Associated Infection
- Being tested
- Pre-moistened wipes
- Keywords
- hygiene
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-moistened wipesProcedure or surgery
Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water. Receives: Procedure: Pre-moistened wipes |
| Control group | No intervention | Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (5)
Compare the total costs of the aids used in the two hygiene methods
Cost of materials and personnel
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start20 Feb 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care Associated InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Azienda Ospedaliera, Ospedale Civile di Legnano
- Responsible party
- Principal investigator, Lea Godino, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514131
- Sponsor's protocol ID
- IGIENE-FAST
- Acronym
- IGIENE-FAST
- Status last verified
- Aug 2026
- First submitted
- 11 Nov 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06514131
- Acronym / sponsor ID
- IGIENE-FAST / IGIENE-FAST
- Conditions
- Health Care Associated Infection
- Keywords
- hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Azienda Ospedaliera, Ospedale Civile di Legnano
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Pre-moistened wipesParticipants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water. |
| Control group | No intervention | –Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-moistened wipesPatients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water | Procedure or surgery | Experimental group |
Primary outcome
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.
5 secondary outcomes
Compare the total costs of the aids used in the two hygiene methods
Time frame: One day
Compare the working times referred to the two hygiene methods
Time frame: One day
Compare the patients' satisfaction with the two hygiene methods
Time frame: One day
Compare the approval of health professionals for the two hygiene methods
Time frame: One day
Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-moistened wipes in people with Health Care Associated Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.