Clinical trial Recruiting at 1 site Interventional

Predicting and preventing surgical wound infections after brain or spinal tumor surgery

Official title: A Prospective, Single-Center Clinical Validation Study: Machine Learning Model-Based Risk Stratification Intervention for Reducing Surgical Site Infection After Central Nervous System Tumor Surgery

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT07378683 · Data updated 2026-11-12

This trial will test whether a machine-learning tool that flags people having brain or spine tumor surgery for extra infection-prevention care can lower their risk of surgical wound infections.

Quick facts

Study typeInterventional
SexAll
Enrollment500 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Locations1 site (Beijing, PUMC)
StatusRecruiting
StartedJune 1, 2025
Main results expectedOctober 30, 2029
Study endsOctober 30, 2029
Registry record updatedJanuary 30, 2026
Trial IDNCT07378683 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (age ≥18) with pathologically confirmed primary or metastatic brain or spinal tumors scheduled for elective tumor resection who expect to survive more than three months and can consent are the intended participants.

Probably not a fit

Patients with an active infection before surgery, recent therapeutic antibiotic use, severe immunosuppression, pregnancy or lactation, or contraindications to the planned antibiotics are unlikely to benefit or be eligible for the intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses an intelligent prediction model to generate individualized risk scores for patients undergoing elective craniotomy or spinal tumor resection and applies an enhanced bundle of preventive measures for those identified as high risk while others receive standard postoperative care. The model is built with machine learning and explainable AI methods (including SHAP) to make risk drivers transparent to clinicians. Eligible adults with pathologically confirmed primary or metastatic CNS tumors will be enrolled at a single center and followed for postoperative surgical site infections. The primary goal is to compare infection rates between model-guided enhanced prevention and standard care.

Why it matters

Potential benefit: If successful, using the model to target extra preventive measures could reduce postoperative wound infections and shorten recovery after brain or spine tumor surgery.

How similar studies have gone: The investigator group has previously developed a highly accurate retrospective prediction model, but prospective use of such models to guide preventive interventions in CNS tumor surgery is still largely untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, Pumc, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.