UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057028 |
|---|---|
| Receipt number | R000065135 |
| Scientific Title | Assessment of the effectiveness of microporous tape in wound healing after total knee arthroplasty |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/14 16:00:51 |
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Basic information
Public title
Assessment of the effectiveness of microporous tape in wound healing after total knee arthroplasty
Acronym
Assessment of the effectiveness of microporous tape in wound healing after total knee arthroplasty
Scientific Title
Assessment of the effectiveness of microporous tape in wound healing after total knee arthroplasty
Scientific Title:Acronym
Assessment of the effectiveness of microporous tape in wound healing after total knee arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of microporous tape in wound healing after total knee arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and Observer Scar Assessment Scale (POSAS) 3.0
Key secondary outcomes
Wound complications, Patient-reported outcome measures (Patient satisfaction evaluated using a Likert scale, Knee Society Score-2011, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, Forgotten Joint Score-12, EuroQol 5-Dimension)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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 |
Interventions/Control_1
Using microporous tape, which is reported to reduce the risk of hypertrophic scar formation on the surgical wound after total knee arthroplasty.
Interventions/Control_2
Not using microporous tape on the surgical wound after total knee arthroplasty (same as the current standard treatment).
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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing primary bilateral total knee arthroplasty for osteoarthritis
Key exclusion criteria
Diseases other than medial osteoarthritis of the knee, use of antiplatelet drugs, anticoagulants, or oral steroids, patients with diabetes, dementia, a history of keloids, or tape allergy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Masuda |
Organization
Tanabe Central Hospital
Division name
Orthopedic surgery
Zip code
6460042
Address
147 Minamishinmachi, Tanabe-city, Wakayama
TEL
+81-739-24-5333
riro_and_tigger@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Masuda |
Organization
Tanabe Central Hospital
Division name
Orthopedic surgery
Zip code
6460042
Address
147 Minamishinmachi, Tanabe-city, Wakayama
TEL
+81-739-24-5333
Homepage URL
riro_and_tigger@yahoo.co.jp
Sponsor or person
Institute
Tanabe Central Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Tanabe CentralHospital
Address
147 Minamishinmachi, Tanabe-city, Wakayama
Tel
+81-739-24-5333
riro_and_tigger@yahoo.co.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
| 2025 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065135
