UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056337 |
|---|---|
| Receipt number | R000064366 |
| Scientific Title | Prevention of Skin Damage Using Disposable Retractors in Open Hepatobiliary Surgery: A Non-Randomized Controlled Trial Comparing Film Drapes and Sewn Gauze |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2024/12/02 17:13:02 |
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Basic information
Public title
Investigation of Skin Injury Prevention Methods Associated with Retractors in Open Surgery Under General Anesthesia
Acronym
Investigation of Skin Injury Prevention Methods
Scientific Title
Prevention of Skin Damage Using Disposable Retractors in Open Hepatobiliary Surgery: A Non-Randomized Controlled Trial Comparing Film Drapes and Sewn Gauze
Scientific Title:Acronym
Prevention of Skin Injury in Open Hepatobiliary and Pancreatic Surgery
Region
| Japan |
Condition
Condition
Skin Injury
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to compare two methods for preventing skin injury associated with the use of disposable retractors: applying film drapes to the abdomen and placing sewn gauze.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or Absence of Skin Injury at the Site of the Disposable Retractor After Surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Apply a film drape to the abdomen and position the disposable retractor.
Interventions/Control_2
Place sewn gauze between the disposable retractor and the skin.
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.Surgery
2.Hepatobiliary and Pancreatic Surgery
3.Open Surgery
4.Adult patients aged 20 years and older
5.General Anesthesia
6.All ASA Classification
7.No gender restriction
Key exclusion criteria
1.Emergency Surgery Patients
2.Other patients deemed inappropriate by the study investigator as research subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Reika |
| Middle name | |
| Last name | Tachibana |
Organization
NHO Nagasaki Medical Center
Division name
Department of Nursing
Zip code
856-8562
Address
2-1001-1 Kuhara, Omura City, Nagasaki Prefecture, Japan
TEL
0957-52-3121
tachibana.reika.mc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Reika |
| Middle name | |
| Last name | Tachibana |
Organization
NHO Nagasaki Medical Center
Division name
Department of Nursing
Zip code
856-8562
Address
2-1001-1 Kuhara, Omura City, Nagasaki Prefecture, Japan
TEL
0957-52-3121
Homepage URL
tachibana.reika.mc@mail.hosp.go.jp
Sponsor or person
Institute
Independent Administrative Institution NHO (Nagasaki Medical Center Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
SGH Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Nagasaki Medical Center
Address
2-1001-1 Kuhara, Omura City, Nagasaki Prefecture, Japan
Tel
0957-52-3121
tachibana.reika.mc@mail.hosp.go.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 | 02 | 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
57
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 04 | 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 | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064366
