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Water Hygiene Versus Waterless Hygiene Technology for Totally Dependent Hospitalized Patients (IGIENE-FAST)

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Health Care Associated Infection

Treatments

Procedure: Pre-moistened wipes

Study type

Interventional

Funder types

Other

Identifiers

NCT06514131
IGIENE-FAST

Details and patient eligibility

About

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.

Full 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.

Enrollment

648 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

648 participants in 2 patient groups

Experimental group
Experimental group
Description:
Participants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water.
Treatment:
Procedure: Pre-moistened wipes
Control group
No Intervention group
Description:
Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water.

Trial contacts and locations

5

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Central trial contact

Domenica Gazineo

Data sourced from clinicaltrials.gov

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