UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037060 |
|---|---|
| Receipt number | R000042223 |
| Scientific Title | Effect of primary negative pressure wound closure for surgical site infection after coronary artery bypass grafting |
| Date of disclosure of the study information | 2019/06/14 |
| Last modified on | 2020/02/10 11:42:31 |
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Basic information
Public title
Effect of primary negative pressure wound closure for surgical site infection
Acronym
Effect of primary negative pressure wound closure
Scientific Title
Effect of primary negative pressure wound closure for surgical site infection after coronary artery bypass grafting
Scientific Title:Acronym
Effect of primary negative pressure wound closure
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of negative pressure wound closure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence rate of SSI
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
CABG patients
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School
Division name
Cardiovascular surgery
Zip code
113-0021
Address
1-1-5 Sendagi Bunkyo Tokyo
TEL
03-3822-2131
m-fujii@nms.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School
Division name
Cardiovascular surgery
Zip code
113-0021
Address
1-1-5 Sendagi Bunkyo Tokyo
TEL
03-3822-2131
Homepage URL
m-fujii@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Alumni Association
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
Nippon Medical School
Address
1-1-5 Sendagi Bunkyo Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.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 | 06 | Month | 14 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00595-019-01912-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00595-019-01912-8
Number of participants that the trial has enrolled
231
Results
Negative-pressure sternal wound closure(NPSWC) significantly reduced the SSI incidence from 10.6 to 2.9%. A multivariate logistic regression analysis identified female sex (p=0.0040) and no NPSWC (p=0.0084) as significant risk factors for sternal SSI development.
Results date posted
| 2020 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 08 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
the SSI incidence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 10 | Day |
Other
Other related information
To collect the data from medical record retrospectively and compare the primary negative pressure wound closure to the conventional closure regarding SSI incidence rate.
Management information
Registered date
| 2019 | Year | 06 | Month | 13 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042223
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
