UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056302 |
|---|---|
| Receipt number | R000064331 |
| Scientific Title | The Effect of Preoperative Skin Care on Transepidermal Water Loss in Patients Undergoing Lithotomy Position Surgery with General Anesthesia |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/06/03 13:59:53 |
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Basic information
Public title
The Effect of Preoperative Skin Care on the Skin Condition of Patients Undergoing Surgery with General Anesthesia
Acronym
The Effect of Preoperative Skin Care on Skin Condition
Scientific Title
The Effect of Preoperative Skin Care on Transepidermal Water Loss in Patients Undergoing Lithotomy Position Surgery with General Anesthesia
Scientific Title:Acronym
The Effect of Preoperative Skin Care on Transepidermal Water Loss
Region
| Japan |
Condition
Condition
Skin Disorders
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to determine whether preoperative skincare using moisturizers reduces TEWL (Transepidermal Water Loss) in surgical patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal Water Loss (TEWL)
Key secondary outcomes
Stratum corneum moisture content, skin pH, and skin condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The moisturizer will be applied three times, over two days, from the admission day until the day before surgery.
Interventions/Control_2
The moisturizer will not be applied from the admission day until the day before surgery.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age: 18 years or older
2. Gender: No restrictions
3. Surgical procedure: Laparoscopic lower gastrointestinal surgery
4.Patients who have received sufficient explanation about the study and have provided written informed consent based on full understanding and their own free will.
Key exclusion criteria
1.Emergency surgery
2.Patients diagnosed with skin diseases
3.Other patients who, in the judgment of the attending physician, are deemed unsuitable for participation in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Terumitsu |
| Middle name | |
| Last name | Sawai |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Division of Nursing Practice Science, Department of Health Sciences
Zip code
850-0862
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture, Japan
TEL
095-819-7990
sawai@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Reika |
| Middle name | |
| Last name | Tachibana |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Division of Nursing Practice Science, Department of Health Sciences
Zip code
850-0862
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture, Japan
TEL
095-819-7990
Homepage URL
bb55224003@ms.nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NHO Nagasaki Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the School of Health Sciences, Graduate School of Biomedical Sciences, Nagasaki University
Address
1-12-4 Sakamoto, Nagasaki City, Nagasaki Prefecture, Japan
Tel
0957-52-3121
gakujutu_gakuji@ml.nagasaki-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | 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
100
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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064331
