UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053356 |
|---|---|
| Receipt number | R000060900 |
| Scientific Title | Skin Disorders in Patients Undergoing Lateral Decubitus Surgery |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/07/01 12:34:52 |
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Basic information
Public title
Association between Preoperative Cutaneous Conditions and the Incidence of Postoperative Skin Disorders in Patients Undergoing Lateral Decubitus Surgery Under General Anesthesia: A Prospective Cohort Study
Acronym
Skin Disorders in Patients Undergoing Lateral Decubitus Surgery
Scientific Title
Skin Disorders in Patients Undergoing Lateral Decubitus Surgery
Scientific Title:Acronym
Skin Disorders in Patients Undergoing Lateral Decubitus Surgery
Region
| Japan |
Condition
Condition
Thoracoscopic pneumonectomy
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the correlation between postoperative skin impairment and pressure ulcer development by measuring transepidermal water loss immediately before surgery at the side chest sites prone to skin damage and pressure ulcers in patients undergoing general anesthesia in the lateral decubitus position, a posture associated with a high incidence of these conditions during the perioperative period.
Basic objectives2
Others
Basic objectives -Others
Calculation of cutoff values that may lead to postoperative skin damage and pressure ulcer development
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trans-epidermal water transpiration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Age: 20 years old or older
(2) Gender: any gender
(iii) Technique: Thoracoscopic pneumonectomy
(4) Surgery time: more than 3 hours (5) Surgical position: supine
Surgical position: Lying on the side
(6) ASA classification: 1-3 (7) Anesthesia method: general anesthesia
(7) Anesthesia method: general anesthesia
Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will.
Key exclusion criteria
(1) Emergency surgery
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
856-8562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81957523121
haraken1124@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
8568562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81957523121
Homepage URL
haraken1124@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagasaki Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nagasaki Medical Center
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
National Hospital Organization Nagasaki Medical Center Ethics Review Committee
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
Tel
+81957523121
haraken1124@gmail.com
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 | 01 | Month | 16 | 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
86
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
| 2022 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background included measurements of age, gender, height, weight, BMI, comorbidities, nutritional status (preoperative ALB, preoperative TP, preoperative Hb), preoperative transepidermal water loss, preoperative skin viscoelasticity, preoperative stratum corneum moisture content, and preoperative skin pH. Surgical and anesthesia factors collected were core temperature (at the start and end of surgery), surgical duration, anesthesia duration, type of anesthesia, total intraoperative fluid volume, intraoperative urine output, intraoperative blood loss, and transfusion occurrence. Postoperative factors included the collection of data on postoperative skin impairment and pressure ulcers.
Management information
Registered date
| 2024 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060900
