UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049716 |
|---|---|
| Receipt number | R000056631 |
| Scientific Title | Development and validation of a risk scoring system to predict surgical-site infection after soft-tissue sarcoma resection: A single center retrospective study |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2022/12/07 16:48:03 |
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Basic information
Public title
Development and validation of a risk scoring system to predict surgical-site infection after soft-tissue sarcoma resection: A single center retrospective study
Acronym
Development and validation of a risk scoring system to predict surgical-site infection after soft-tissue sarcoma resection: A single center retrospective study
Scientific Title
Development and validation of a risk scoring system to predict surgical-site infection after soft-tissue sarcoma resection: A single center retrospective study
Scientific Title:Acronym
Development and validation of a risk scoring system to predict surgical-site infection after soft-tissue sarcoma resection: A single center retrospective study
Region
| Japan |
Condition
Condition
soft-tissue sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, the correlations of various risk factors, including age, body mass index (BMI), diabetes, smoking, tumor location, tumor depth, tumor size, operative time, skin graft or flap, preoperative chemotherapy, and radiation therapy, with SSI were investigated.
Basic objectives2
Others
Basic objectives -Others
A risk scoring system for the individual risk assessment of SSI was developed by combining these risk factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The associations of various variables (age, body mass index, diabetes, smoking during the previous year, tumor location, tumor depth, resected tumor size, operative time, skin graft or flap, preoperative chemotherapy, and radiation therapy) with SSI were evaluated in a cohort of 471 patients. Furthermore, a scoring system was developed by combining these risk factors, and the predictive power of the scoring system was evaluated in another cohort of 76 patients.
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
Patients with soft-tissue sarcoma who underwent surgical resection between January 2005 and December 2021
Key exclusion criteria
Incomplete information regarding the clinical parameter or treatment of the patients.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Miwa |
Organization
Graduate School of Medical Science, Kanazawa University
Division name
Department of Orthopedic Surgery
Zip code
920-8640
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
0762652374
miwapoti@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Miwa |
Organization
Graduate School of Medical Science, Kanazawa University
Division name
Department of Orthopedic Surgery
Zip code
920-8640
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
0762652374
Homepage URL
miwapoti@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Graduate School of Medical Science, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Science, Kanazawa University
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
The ethics committee of Kanazawa University
Address
13-1 Takara-machi, Kanazawa, Ishikawa
Tel
0762652374
miwapoti@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
| 2022 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
547
Results
Age, diabetes, smoking during the previous year, operative time, and radiation therapy, were independent risk factors for SSI. A risk scoring system combining these factors was developed. In another cohort of 76 patients, risk scores of 2 points or more were significantly correlated with increased risk of SSI.
Results date posted
| 2022 | Year | 12 | Month | 07 | Day |
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
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056631
