UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059500 |
|---|---|
| Receipt number | R000068059 |
| Scientific Title | Non-inferior comparative study comparing one day or intraoperative antimicrobial prophylaxis after clean orthopaedic surgery (NOCOTA study): a cluster randomized controlled trial comparing duration of antibiotic prophylaxis. |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/10/22 13:52:37 |
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Basic information
Public title
Non-inferior comparative study comparing one day or intraoperative antimicrobial prophylaxis after clean orthopaedic surgery (NOCOTA study): a cluster randomized controlled trial comparing duration of antibiotic prophylaxis.
Acronym
NOCOTA2 trial
Scientific Title
Non-inferior comparative study comparing one day or intraoperative antimicrobial prophylaxis after clean orthopaedic surgery (NOCOTA study): a cluster randomized controlled trial comparing duration of antibiotic prophylaxis.
Scientific Title:Acronym
NOCOTA2 trial
Region
| Japan |
Condition
Condition
Clean orthopedic surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the efficacy of administering prophylactic antibiotics within 24 hours postoperatively versus administering them only intraoperatively in patients undergoing clean orthopedic surgery requiring hospitalization.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is defined as complications requiring postoperative treatment with antimicrobial agents (excluding antiviral, antifungal, and antituberculosis drugs) occurring within 30 days postoperatively (with the day of surgery designated as Day 0). Such infection is called as HAI(Health care associated infection) including SSI, UTI, RTI, and other infectious diseases. HAI will be assessed between 31 and 180 days postoperatively.
Key secondary outcomes
Secondary endpoints include the incidence rates of surgical site infections (SSI), urinary tract infections, respiratory infections, and other infections; the 30-day postoperative mortality rate; the incidence rate of cardiovascular events; the rate of continued hospitalization beyond 30 days postoperatively; and the proportion of resistant bacteria among pathogens causing postoperative SSI. Such status will be assessed between 31 and 180 days postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For patients undergoing clean orthopedic surgery requiring hospitalization, establish a postoperative antibiotic administration group receiving prophylactic antibiotics within 24 hours. The antibiotic used is cefazolin; clindamycin or vancomycin is used for patients with allergies.
Interventions/Control_2
For patients undergoing inpatient surgery at the Clean Surgery Center, establish a group receiving prophylactic antibiotics administered only during surgery. The antibiotic used is cefazolin; clindamycin or vancomycin is used for patients with allergies.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 or older at the time of consent acquisition.
2) Inpatients undergoing surgery performed by orthopedic surgeons, rheumatology surgeons, or orthopedic surgeons in the emergency department.
3) The surgery is clean surgery. It corresponds to Class I (clean surgery) in the CDC wound classification.
4) Possesses the ability to read and understand Japanese.
5) Verifiable consent for study participation can be obtained verbally or in writing from the subject or a proxy consent provider (relative).
6) The surgery involves primary closure of the wound.
Key exclusion criteria
1) When part of an internal fixation device protrudes outside the body; external fixation, percutaneous pinning, etc.
2) Amputation surgery
3) Needle biopsy
4) Surgical removal of pins
5) Skin flaps or grafts involving skin tissue
6) Antibiotics, antiviral drugs, antifungal drugs, or anti-tuberculosis drugs are being administered at the time of surgical decision
7) Percutaneous vertebral augmentation; Balloon Kyphoplasty, Vertebral Plasty, etc.
8) Spinal fusion involving four or more vertebral segments
9) Surgery performed in collaboration with other departments
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Oka |
Organization
Faculty of Medicine, The University of Tokyo,
Division name
Division of Musculoskeletal AI System Development,
Zip code
113-8655
Address
7-3-1, Bunkyo-ku, Hongo, Tokyo
TEL
03-3815-5411
taigis54@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Nagata |
Organization
Saitama Medical University, Saitama Medical Center
Division name
Dpartment of orthopedic surgery
Zip code
350-0844
Address
1981 Kamoda, Kawagoe City, Saitama
TEL
049-228-3411
Homepage URL
knagata-tky@umin.ac.jp
Sponsor or person
Institute
Saitama Medical University, Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jikei University School of Medicine
Yokohama City University
Toho University Ohashi Hospital
St. Marianna University School of Medicine
Nara Municipal Hospital
Hokusui Memorial Hospital
Yoneshige Hospital
Kakogawa Medical Center
Nagata Orthopedic Hospital
Saiseikai Central Hospital
Name of secondary funder(s)
Japan Orthopedic Association
IRB Contact (For public release)
Organization
Saitama Medical University Research Administration Center
Address
1981 Kamoda, Kawagoe City, Saitama
Tel
049-228-3411
smcrinri@saitama-med.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 | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068059
