Washcloths Effectiveness in Preventing Pressure Ulcers (Bathing)
Primary Purpose
Pressure Ulcer, Skin Ulcer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
3-in-1 perineal care washcloths
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer
Eligibility Criteria
Inclusion Criteria:
- All patients (real-world)
Exclusion Criteria:
- Under 18 yo
- Patients who present allergic reactions or sensitivity to the experimental procedure
Sites / Locations
- IRCCS Policlinico San Donato
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
standard
Arm Description
The 3-in-1 perineal care washcloth procedure has been adopted to deliver hygiene care (total or perineal) or baths
The deliver of hygiene care (total or perineal) or baths has been performed using water and pH neutral soap
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03445975
First Posted
February 15, 2018
Last Updated
February 20, 2018
Sponsor
Ospedale San Donato
1. Study Identification
Unique Protocol Identification Number
NCT03445975
Brief Title
Washcloths Effectiveness in Preventing Pressure Ulcers
Acronym
Bathing
Official Title
Preventing Pressure Ulcers (PU) in Intensive Care Units - The Effectiveness of Dry Washcloths Versus Usual Care: A Cluster-crossover Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Skin Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The 3-in-1 perineal care washcloth procedure has been adopted to deliver hygiene care (total or perineal) or baths
Arm Title
standard
Arm Type
No Intervention
Arm Description
The deliver of hygiene care (total or perineal) or baths has been performed using water and pH neutral soap
Intervention Type
Procedure
Intervention Name(s)
3-in-1 perineal care washcloths
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure Ulcer
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients (real-world)
Exclusion Criteria:
Under 18 yo
Patients who present allergic reactions or sensitivity to the experimental procedure
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
MI - Milano
ZIP/Postal Code
20097
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21952346
Citation
Beeckman D, Verhaeghe S, Defloor T, Schoonhoven L, Vanderwee K. A 3-in-1 perineal care washcloth impregnated with dimethicone 3% versus water and pH neutral soap to prevent and treat incontinence-associated dermatitis: a randomized, controlled clinical trial. J Wound Ostomy Continence Nurs. 2011 Nov-Dec;38(6):627-34. doi: 10.1097/WON.0b013e31822efe52.
Results Reference
background
PubMed Identifier
17413828
Citation
Bliss DZ, Zehrer C, Savik K, Smith G, Hedblom E. An economic evaluation of four skin damage prevention regimens in nursing home residents with incontinence: economics of skin damage prevention. J Wound Ostomy Continence Nurs. 2007 Mar-Apr;34(2):143-52; discussion 152. doi: 10.1097/01.WON.0000264825.03485.40.
Results Reference
background
PubMed Identifier
27630803
Citation
Truong B, Grigson E, Patel M, Liu X. Pressure Ulcer Prevention in the Hospital Setting Using Silicone Foam Dressings. Cureus. 2016 Aug 8;8(8):e730. doi: 10.7759/cureus.730.
Results Reference
background
PubMed Identifier
26125031
Citation
Harris PN, Le BD, Tambyah P, Hsu LY, Pada S, Archuleta S, Salmon S, Mukhopadhyay A, Dillon J, Ware R, Fisher DA. Antiseptic Body Washes for Reducing the Transmission of Methicillin-Resistant Staphylococcus aureus: A Cluster Crossover Study. Open Forum Infect Dis. 2015 May 22;2(2):ofv051. doi: 10.1093/ofid/ofv051. eCollection 2015 Apr.
Results Reference
background
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Washcloths Effectiveness in Preventing Pressure Ulcers
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