UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037509 |
|---|---|
| Receipt number | R000042761 |
| Scientific Title | The comparison of wound complications after total joint replacement between barbed suture and traditional suture: a randomized control trial |
| Date of disclosure of the study information | 2019/07/27 |
| Last modified on | 2021/01/27 10:32:45 |
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Basic information
Public title
The comparison of wound complications after total joint replacement between barbed suture and traditional suture: a randomized control trial
Acronym
The comparison of wound complications after total joint replacement between barbed suture and traditional suture: a randomized control trial
Scientific Title
The comparison of wound complications after total joint replacement between barbed suture and traditional suture: a randomized control trial
Scientific Title:Acronym
The comparison of wound complications after total joint replacement between barbed suture and traditional suture: a randomized control trial
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does the barbed suture increase the wound complications?
Basic objectives2
Others
Basic objectives -Others
How does the barbed suture increase the cost?
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The wound complication after total joint replacement during 1 month
Key secondary outcomes
The increase of cost in using barbed suture
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Barbed suture or not (traditional suture). When suturing the subcutaneous layer, surgeon will use barbed suture or traditional suture. During research period, this intervention will be used.
Interventions/Control_2
Conventional suture. During research period, this intervention will be used.
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
| 45 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent total joint replacement due to osteoarthritis of the knee or hip
Key exclusion criteria
Patients who have disease affecting wound healing, patients who denied participant, or patients who underwent total joint replacement due to except osteoarthritis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Tanabe Central Hospital
Division name
Orthopedic surgery
Zip code
6440042
Address
147 minamisinnmachi tanabeshi wakayama
TEL
0739-24-5333
h.ueyama@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Tanabe Central Hospital
Division name
Orthopedic surgery
Zip code
6440042
Address
147 minamisinnmachi tanabeshi wakayama
TEL
0739-24-5333
Homepage URL
h.ueyama@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Tanabe Central Hospital, Orthopedic surgery
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Institutional Review Board For Human Subjects TANABE CENTRAL HOSPITAL
Address
147 minamisinnmachi tanabeshi wakayama
Tel
0739-24-5333
h.ueyama@msic.med.osaka-cu.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
| 2019 | Year | 07 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042761
