UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047144 |
|---|---|
| Receipt number | R000053776 |
| Scientific Title | Effect of the method of applying the iodine compound drape on its adhesiveness |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2024/09/12 15:14:12 |
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Basic information
Public title
Effect of the method of applying the iodine compound drape on its adhesiveness
Acronym
iodine compound drape
Scientific Title
Effect of the method of applying the iodine compound drape on its adhesiveness
Scientific Title:Acronym
iodine compound drape
Region
| Japan |
Condition
Condition
knee surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether the difference in the conditions for applying the drape effects the adhesive strength of the drape used during knee surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The area where the drape is peeled off
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Attached at knee extension position, without wrinkled drape
Interventions/Control_2
Attached at knee extension position, with wrinkled drape
Interventions/Control_3
Attached at knee flexion position, without wrinkled drape
Interventions/Control_4
Attached at knee flexion position, with wrinkled drape
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult volunteers
Key exclusion criteria
Persons with a history of knee trauma
Persons with knee disease
Persons who are allergic to iodine compounds
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Matsui |
Organization
Osaka City General Hospital
Division name
Orthopaedics
Zip code
534-0021
Address
2-13-22 Miyakojimahondori Miyakojima Osaka Japan
TEL
0669291221
ichi23@js3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Matsui |
Organization
Osaka City General Hospital
Division name
Orthopaedics
Zip code
5340021
Address
2-13-22 Miyakojimahondori Miyakojima Osaka Japan
TEL
0669291221
Homepage URL
ichi23@js3.so-net.ne.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City General Hospital
Address
2-13-22 Miyakojimahondori Miyakojima Osaka Japan
Tel
0669291221
ichi23@js3.so-net.ne.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
| 2022 | Year | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2027 | 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 | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053776
