Health Care Associated Infection
Conditions
Keywords
hygiene
Brief 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.
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.
Interventions
PROCEDUREPre-moistened wipes
Patients receiving the experimental treatment will have perineal hygiene performed with the pre-moistened wipes without water
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Azienda USL - IRCCS di Reggio Emilia
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Azienda Ospedaliera, Ospedale Civile di Legnano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes | 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
| Measure | Time frame | Description |
|---|---|---|
| Compare the total costs of the aids used in the two hygiene methods | One day | Cost of materials and personnel |
| Compare the working times referred to the two hygiene methods | One day | Time expressed in minutes, required for the completion of perineal hygiene for each methodology |
| Compare the patients' satisfaction with the two hygiene methods | One day | Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome) |
| Compare the approval of health professionals for the two hygiene methods | One day | Assessed by a specific ad hoc questionnaire ranging from 2 to 10 (higher scores mean a better outcome) |
| Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies | One day | Assessed by a specific ad hoc questionnaire (list of items) |
Countries
Italy
Outcome results
None listed