Clean orthopedic surgery
Conditions
Interventions
For patients undergoing clean orthopedic surgery requiring hospitalization, establish a postoperative antibiotic administration group receiving prophylactic antibiotics within 24 hours. The antibiotic
clindamycin or vancomycin is used for patients with allergies.
For patients undergoing inpatient surgery at the Clean Surgery Center, establish a group receiving prophylactic antibiotics administered
clindamycin or vancomycin is used for patients with allergies.
Sponsors
Saitama Medical University, Saitama Medical Center
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
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKosei Nagata
Saitama Medical University, Saitama Medical Center Dpartment of orthopedic surgery
Outcome results
None listed