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A Clinical Prediction Model for Surgical Site Infection After Central Nervous System Tumor Surgery

RecruitingNAAges any - anyAllMing Yang
NCT07378683 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

1. Study Background For patients undergoing brain or spinal tumor surgery, postoperative surgical wound infection (known as "surgical site infection," SSI) is a recognized risk. Once an infection occurs, it may complicate and prolong the recovery process. Currently, doctors primarily rely on clinical experience to judge which patients are at higher risk of infection. Our research team has previously developed an intelligent prediction model (a machine learning tool) that can very accurately identify which patients are at higher risk of postoperative infection. This study aims to validate whether implementing enhanced preventive measures for high-risk patients in advance, based on the model's predictions, can effectively reduce the occurrence of infection. 2. Study Purpose The primary purpose of this study is to validate whether an individualized intervention strategy based on an intellig

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with a pathologically confirmed primary or metastatic central nervous system (brain or spinal) tumor. 2. Scheduled for elective craniotomy or spinal tumor resection surgery. 3. Age ≥ 18 years. 4. Expected survival \> 3 months, and able/willing to comply with postoperative follow-up. 5. Voluntary participation and provision of written informed consent. Exclusion Criteria: 1. Presence of active systemic or local surgical site infection before surgery. 2. Use of therapeutic antibiotics for any reason within 72 hours prior to surgery. 3. Concurrent severe immunosuppressive conditions, or chronic use of high-dose immunosuppressants. 4. Pregnancy or lactation. 5. Known contraindications or severe allergy to the antibiotics planned for use in the study. 6. Any other condition that, in the investigator's judgment, may affect study participation or outcome assessment.
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What it tests

  • ML-Based Enhanced Intervention Package for SSI Prevention
  • Standard Postoperative Care
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Where

1 site
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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