UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030929 |
|---|---|
| Receipt number | R000035321 |
| Scientific Title | Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/01/25 09:04:48 |
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Basic information
Public title
Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery
Acronym
NOCOTA study
Scientific Title
Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery
Scientific Title:Acronym
NOCOTA study
Region
| Japan |
Condition
Condition
Clean orthopedic surgeries which required hospitalization
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the effectiveness of preventive antibiotics within 24 hours and within 24-48 hours after clean orthopedic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical site infections, urinary tract infections, respiratory tract infections, or other infections which required the use of antibiotics within 30 days after orthopedic surgery
Key secondary outcomes
other adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of prophylactic antibiotics within 24 hours after surgery
Interventions/Control_2
Administration of prophylactic antibiotics within 24-48 hours after surgery
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
1) aged 20 years or older,
2) hospitalized patients,
3) clean surgery,
4) patient with a good command of Japanese,
5) who were able to give consent on their own or through relatives,
6) who had a primary intention wound closure.
Key exclusion criteria
1) operations involving use of external fixations,
2) amputations,
3) needle biopsies,
4) implant removal,
5) reconstructive surgery involving skin tissue such as flap surgery,
6) patients receiving antibiotic therapy prior to surgery,
7) percutaneous vertebroplasty (balloon kyphoplasty, vertebroplasty, etc.)
8) procedures performed in collaboration with other departments.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okazaki |
Organization
Kanto Rosai Hospital
Division name
Department of orthopedic surgery
Zip code
211-8510
Address
1-1 Kizukisumiyoshi-cho, Nakahara-ku , Kawasaki City, Kanagawa Prefecture, Japan
TEL
044-411-3131
okazarov@kantoh.johas.go.jp
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Nagata |
Organization
the University of Tokyo Hospital
Division name
Department of Orthopaedic Surgery and Spinal Surgery
Zip code
112-8655
Address
7-3-1Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
http://ossi.jp/about/
knagata-tky@umin.ac.jp
Sponsor or person
Institute
Society for Orthopaedic Surgical Site Infection
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Organization of Occupational Health and Safety Kanto Rosai Hospital
Address
1-1 Kizukisumiyoshi-cho, Nakahara-ku , Kawasaki City, Kanagawa Prefecture, Japan
Tel
044-411-3131
ossijapan@gmail.com
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
東京都立広尾病院（東京都）
関東労災病院（神奈川県）
東京都立駒込病院（東京都）
東京都立多摩総合病院整形外科（東京都）
東京都健康長寿医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://ossi.jp/info/
Publication of results
Unpublished
Result
URL related to results and publications
http://ossi.jp/info/
Number of participants that the trial has enrolled
1232
Results
The SSI and HAI rate may be equivalent between Group 24 and Group 48.
Results date posted
| 2019 | Year | 08 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The statistical analysis will need long time.
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 30 | Day |
Baseline Characteristics
(1) age more than 20 years; (2) hospitalized patients; (3) patients who underwent clean surgery based on CDC wound classification system; (4) patients with a good command of the Japanese language; (5) patients able to give consent on their own or through relatives; and (6) a primary intention wound closure.
Participant flow
In this study, patients will be divided into two groups of different AMP duration using the institution-by-period cluster allocation system. Patients will not be informed of allocation schedule preoperatively.
Adverse events
Adverse events, including anaphylaxis, will not be observed.
Outcome measures
Patients' background and (1) SSI, (2) UTI, (3) RTI, or (4) other infectious diseases. Secondary outcomes will include the prevalence of diseases (1)-(4), (5)mortality, (6) cardiovascular events observed within 30 days after surgery, (7) prolonged hospitalization for >30 days, and (8) the rate of antibiotic resistance of SSI pathogens.
Plan to share IPD
no
IPD sharing Plan description
no
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
The patient registration was terminated on December 31, 2018. Data were fixed around June 30, 2019. In order to evaluate the onset of infection within 30 days after surgery. Data analysis was conducted by the end of March 2020.Submission will be performed by August 2020.
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2022 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035321
