UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048846 |
|---|---|
| Receipt number | R000055662 |
| Scientific Title | A single center, prospective, randomized, open-label cross-over trial of skin wipes versus wash-off techniques for genital bacteria reduction in stroke patients |
| Date of disclosure of the study information | 2022/09/05 |
| Last modified on | 2023/02/11 09:29:00 |
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Basic information
Public title
Evaluation of genital skin cleaning technique in stroke patients: A comparative study
Acronym
Evaluation of genital skin cleaning technique
Scientific Title
A single center, prospective, randomized, open-label cross-over trial of skin wipes versus wash-off techniques for genital bacteria reduction in stroke patients
Scientific Title:Acronym
Evaluation of skin cleaning technique
Region
| Japan |
Condition
Condition
Incontinence-associated dermatitis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of wiping and wash-off techniques for bacterial reduction on genital skin surface.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bacterial reduction (for patients)
Key secondary outcomes
1. Generation of ATP (for patients)
2. Detection of drug-resistant bacteria and urease-producing bacteria (for patients)
3. Usability of wipes (for healthcare professionals)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group,
Cleaning genital areas with wet wipes.
Interventions/Control_2
Control group,
Cleaning genital areas with lukewarm water and gauze.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Stroke patients admitted to the ward where this study is conducted.
2. Patients who use diapers or are expected to use diapers at the beginning of this study.
Key exclusion criteria
1. Patients with pressure injuries on the buttocks, sacrum, or ischial at hospital admission.
2. Hospital stay for less than 30 days.
3. Patients with difficulty in holding the posture for skin observation.
4. Patients who are deemed inappropriate to participate this study, by the principal or study investigators.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Matsushima |
Organization
Fujita Health University Nanakuri Memorial Hospital
Division name
Department of Nursing
Zip code
514-1295
Address
424-1, Oodoricho, Tsu, Mie
TEL
059-252-1555
ayako-ma@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masushi |
| Middle name | |
| Last name | Kohta |
Organization
Fujita Health University
Division name
Research Center for Implementation Nursing Science Initiative
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562-93-2000
Homepage URL
masushi.kota@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
Japan Society of wound, ostomy, and continence management
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
Tel
0562-93-2000
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤田医科大学七栗記念病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055662
