Actively Recruiting
Machine Learning Model-Based Risk Stratification to Reduce Surgical Site Infection After Central Nervous System Tumor Surgery A Prospective, Single-Center Clinical Validation Study
Led by Ming Yang · Updated on 2026-01-30
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a machine learning-based approach to reduce surgical site infections (SSI) in patients undergoing brain or spinal tumor surgery. This study aims to validate whether using an intelligent prediction model to identify high-risk patients and applying tailored preventive measures can lower infection rates. It also assesses safety, hospital stay length, medical costs, and the model's practical feasibility. The study is a prospective, single-center clinical validation conducted at the Chinese Academy of Medical Sciences Cancer Hospital.
CONDITIONS
Brief Title
A Clinical Prediction Model for Surgical Site Infection After Central Nervous System Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed primary or metastatic brain or spinal tumor
- Scheduled for elective craniotomy or spinal tumor surgery
- Age 18 years or older
- Expected survival longer than 3 months and able to comply with follow-up
- Voluntary participation with written informed consent
You will not qualify if you...
- Active systemic or local infection before surgery
- Use of therapeutic antibiotics within 72 hours prior to surgery
- Severe immunosuppressive conditions or chronic high-dose immunosuppressant use
- Pregnancy or breastfeeding
- Known allergy or contraindication to antibiotics planned for the study
- Any condition that may affect participation or outcome as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo elective craniotomy or spinal tumor surgery as part of their treatment.
1 visit (in-person)
Duration - Up to 90 days post-surgery
Participants receive postoperative care based on their risk of surgical site infection determined by a machine learning model. High-risk participants receive an enhanced, individualized intervention package including escalated antibiotic prophylaxis, intensified nutritional support, and enhanced monitoring. Low-risk participants receive standard postoperative care following established clinical pathways.
Follow-up visits as per standard clinical pathways within 90 days
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, PUMC, China, 10010
Actively Recruiting
Research Team
M
Ming Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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