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Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery

Non-inferior comparative study comparing One or Two day antimicrobial prophylaxis in clean orthopaedic surgery - NOCOTA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030929
Enrollment
1000
Registered
2018-04-01
Start date
2018-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clean orthopedic surgeries which required hospitalization

Interventions

Administration of prophylactic antibiotics within 24 hours after surgery Administration of prophylactic antibiotics within 24-48 hours after surgery

Sponsors

Society for Orthopaedic Surgical Site Infection
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Surgical site infections, urinary tract infections, respiratory tract infections, or other infections which required the use of antibiotics within 30 days after orthopedic surgery

Secondary

MeasureTime frame
other adverse events

Countries

Japan

Contacts

Public ContactKosei Nagata

the University of Tokyo Hospital Department of Orthopaedic Surgery and Spinal Surgery

knagata-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026