Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059500) titled '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.' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Saitama Medical University, Saitama Medical Center

Condition: Condition - Clean orthopedic surgery Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 1000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2027 Year 08 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068059

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