UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060877 |
|---|---|
| Receipt number | R000069661 |
| Scientific Title | Seasonal variation and meteorological determinants of surgical site infection after orthopedic surgery: a nationwide retrospective cohort study using the JANIS database |
| Date of disclosure of the study information | 2026/03/09 |
| Last modified on | 2026/03/09 18:52:32 |
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Basic information
Public title
Seasonal Variation and Meteorological Determinants of Surgical Site Infection After Orthopedic Surgery: A Nationwide Cohort Study in Japan
Acronym
ORTHO-SSI Season Study
Scientific Title
Seasonal variation and meteorological determinants of surgical site infection after orthopedic surgery: a nationwide retrospective cohort study using the JANIS database
Scientific Title:Acronym
JANIS-SSI Season Study
Region
| Japan |
Condition
Condition
Orthopedic surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate nationwide seasonal variation in surgical site infection (SSI) after orthopedic surgery in Japan and to evaluate the association between early postoperative meteorological conditions, particularly absolute humidity and temperature, and the risk of SSI using the Japan Nosocomial Infections Surveillance (JANIS) database.
Basic objectives2
Others
Basic objectives -Others
This study is a retrospective observational epidemiological study using the Japan Nosocomial Infections Surveillance (JANIS) database to evaluate seasonal variation in surgical site infection (SSI) after orthopedic surgery and its association with meteorological factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of surgical site infection (SSI) after orthopedic surgery as recorded in the Japan Nosocomial Infections Surveillance (JANIS) database. Superficial incisional SSI occurring within 30 days after surgery and deep incisional or organ/space SSI occurring within 30 days (without implant) or within 1 year (with implant) were included according to standard surveillance definitions.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Orthopedic surgical procedures recorded in the Japan Nosocomial Infections Surveillance (JANIS) database between January 2012 and April 2025 will be included.
Key exclusion criteria
Procedures with missing data for variables required in the primary multivariable analysis, including age, sex, surgery type, operative time, wound class, ASA classification, emergency surgery status, implant use, hospital identifier, or surgery date, will be excluded.
Target sample size
920000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Mimura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
TEL
0263-37-2659
tettim3@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Mimura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
TEL
0263-37-2659
Homepage URL
tettim3@yahoo.co.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Tetsuhiko Mimura
Funding Source
Organization
None
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
Shinshu University School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
Tel
0263-37-3099
mdrinri@shinshu-u.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
| 2026 | Year | 03 | Month | 09 | 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
919763
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
| 2025 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a nationwide retrospective observational study using the Japan Nosocomial Infections Surveillance (JANIS) database. Orthopedic surgical procedures recorded between January 2012 and April 2025 will be analyzed to evaluate seasonal variation in surgical site infection (SSI) and its association with early postoperative meteorological conditions, particularly absolute humidity and temperature. Multivariable models adjusted for patient and surgical characteristics will be used.
Management information
Registered date
| 2026 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069661
