An interventional study of 3-in-1 perineal care washcloths in Pressure Ulcer and Skin Ulcer, sponsored by Ospedale San Donato. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-26.
Sponsored by Ospedale San Donato · Not applicable, Interventional, and Prevention
Among 15 studies in Pressure Ulcer with a site in Italy — 2 open to participants now, 2 under way, none of them phase 3. Pressure Ulcer · Italy.
Among the 15 studies in Pressure Ulcer with a site in Italy, this one is the 6th largest by enrollment of the 12 interventional ones, is one of 4 that started in 2017, is one of 10 with no phase, and was the 8th registered.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's enrollment of 240 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →2 of the 15 studies in Pressure Ulcer with a site in Italy are open now, in 1 country. Each count lists the studies.
Of the 61 Pressure Ulcer studies recruiting now, 45 (74%) set no upper age limit and 6 (10%) stop at 75 or younger; 10 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2017.
Median enrollment 220 across the 12 interventional studies, 565 across the 3 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
2 of 15 have an industry lead sponsor. The 10 most frequent:
Ospedale San Donato is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
Ospedale San Donato has 1 study filed under Pressure Ulcer — fewer than ten, so there is no comparison to draw.
1 of the studies in Pressure Ulcer with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05513508Azienda Ospedaliero Universitaria Maggiore della CaritaThe ROTAtional-USE of Interface STUDY | 2027-09 |
Among the 15 studies in Pressure Ulcer with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
A monocentric cluster-crossover design has been used in this study to test the effectiveness of a 3-in-1 perineal care washcloth versus standard of care (e.g., water and pH neutral soap) to prevent and treat pressure ulcers in ICUs.
This study had a cluster-crossover design, where each of the two involved ICUs was the cluster. The genaral aim was to test the effectiveness of a 3-in-1 perineal care washcloth versus standard of care (e.g., water and pH neutral soap) to prevent and treat pressure ulcers in ICUs. The study has been articulated in two phases, lasted three months each. In the first phase, from the 1st of February to the 2nd of May, the 3-in-1 perineal care washcloth procedure has been adopted by the ICU of San Donato Hospital (Milan, Italy), while the Cardiovascular Intensive Care Unit (CVICU) continued to adopt the standard procedure (water and pH neutral soap). In the second phase, from the 2nd of May to 31st of July, the two procedures have been switched between the two wards.
Adult patients (aged over 18 years old) requiring personal hygiene care (total or perineal) in ICU and CVICU of San Donato Hospital have been enrolled. Patients who present allergic reactions or sensitivity to the experimental procedure have been excluded. All the longitudinal data related to the presence/grading of pressure ulcer (PU) at every hygiene care (total or perineal) performed on the patients in ICU and CVICU have been collected.
The primary endpoint of the study is represented by PU during the hospitalization in ICUs, whis is expected to be reduced from 10% in the experimental clusters. A sample size composed by 240 patients (120 patients/group) has been calculated, following methodological approach for difference between proportions. The sample size was calculated to be representative in observing a 10% decrease in the onset of PU, with a 80% power and an alpha error equal to 0.05. This approach led to the detection of a clinical relevant difference to compare the effectiveness between the two different procedures.
Data collected for the study were recorded on data-collection sheets in hard copy format. Data were also collected after every hygiene procedure on patient-related characteristics, skin condition and general clinical status.
The comparison between the two clusters (i.e. ICU and CVICU) will be performed using Student's t-test for the continuous variables and the χ2 for the categorical ones. Treatment effectiveness will be evaluated through the difference between proportions of IAD and PU in Period 1 and Period 2. A decrease in the onset of IAD and PU is expected as the main endpoint, considering a 95% confidence interval. The data will be compared using generalized estimating equation (GEE). The variables that might have an influence on the prevalence/incidence measures (i.e., patient's characteristics and ICUs management/staffing) will be monitored. The Period will be considered a "within" factor and the procedure/cluster a "between" factor. The α significance level will be preventively set at 5%.
Data have been stored to a master file on the San Donato Hospital server. This is password-protected and only available to the Principal Investigator user. On completion of the project, identifying data have been removed from all the record.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The 3-in-1 perineal care washcloth procedure has been adopted to deliver hygiene care (total or perineal) or baths
Procedure: 3-in-1 perineal care washcloths
The deliver of hygiene care (total or perineal) or baths has been performed using water and pH neutral soap
The 3-in-1 washcloth was used for daily routine perineal skin hygiene and after each diaper/underpad change. This procedure was intended for cleansing, moisturizing, and application of a barrier protection (dimeticone 3%). 3-in1 washcloths pH range is 3.5 to 5.0.
Pressure Ulcer
To describe the impact of 3-in-1 washcloths on pressure ulcers. Pressure ulcers are assessed using the classification proposed by the US-National Pressure Ulcer Advisory Panel (NPUAP)
Time frame: 6 months
Plan to share: Undecided
Ran from Feb 2017 to primary completion in Jul 2017, 5 months.
Of 179 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 5 months is below that.
Counting every sponsor, half of 209 studies reached it within 11 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Ospedale San Donato