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

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

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 intelligent prediction model can effectively reduce the incidence of surgical site infection in patients after central nervous system tumor surgery. Simultaneously, we will also evaluate the safety of this strategy, its impact on patient hospital stay length and medical costs, as well as its feasibility in practical clinical application.

3. Study Design Type: This is a prospective, single-center clinical validation study. "Prospective" means the research plan is established first, followed by patient recruitment and data collection according to the plan; "single-center" indicates the study is conducted solely at the Chinese Academy of Medical Sciences Cancer Hospital.

   Process: For all patients who consent to participate in this study, within 72 hours after surgery, the research system will automatically calculate their infection risk based on 8 key clinical indicators (such as blood test results, medical history, etc.).

   High-Risk Group (model-predicted infection probability ≥50%): Will receive a set of enhanced, individualized infection prevention measures (e.g., adjusted antibiotic regimen, enhanced nutritional support, closer monitoring).

   Low-Risk Group (model-predicted infection probability <50%): Will receive the current standard, high-quality postoperative care.

   Duration: The study is planned to run from February 2026 to October 2029. Each participating patient will be followed for 3 months (90 days) to observe whether infection occurs.

   Sample Size: It is planned to recruit approximately 500 eligible patients.

4. Primary Evaluation Indicators Primary Indicator: The incidence of surgical site infection within 90 days after surgery. The diagnosis of infection will be made by experts who are unaware of the patient's group assignment, strictly following international standards.

   Secondary Indicators: Include the accuracy of the intelligent prediction model in practical use, patient hospital stay length, other infection-related complications, medical costs, and the adoption rate of the model's recommendations by physicians.

5. Eligibility Criteria (Inclusion Criteria Summary)

   You may be eligible to participate in this study if you meet the following conditions:

   Diagnosed with a brain or spinal tumor and scheduled for elective surgery. Aged 18 years or older. Expected survival exceeds 3 months and able to cooperate with postoperative follow-up.

   Voluntary participation and signing of a written informed consent form. (Note: This study has detailed exclusion criteria. Final confirmation of whether all criteria are met will be determined by your study doctor.)

6. Patients' Rights and Safety Voluntary Participation: Participation in this study is entirely voluntary. You have the right to withdraw from the study at any time, which will not affect the quality of any normal medical services you are entitled to at our hospital or your relationship with it.

   Informed Consent: Before the study begins, your study doctor will explain all study procedures, potential risks, and benefits in detail, and you will sign an "Informed Consent Form." Privacy Protection: All your personally identifiable information will be kept strictly confidential. Codes will replace your name and other identifiable information in research analyses and reports.

   Safety Assurance: This study has been reviewed and approved by the hospital's Ethics Committee. We have established an independent Data Safety Monitoring Board to monitor the study's safety throughout. Clinical trial liability insurance has been purchased for all participants to cover damages related to the trial.

7. Contact Information

If you would like to learn more about this study, please contact us via:

Principal Investigator: Dr. Yang Ming National Cancer Center/National Clinical Research Center for Cancer/Cancer Research Unit: Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Overview

• Status: Recruiting
• Conditions: Central Nervous System Tumor; Surgical Site Infection (SSI)
• Intervention / Treatment: Other: ML-Based Enhanced Intervention Package for SSI Prevention; Other: Standard Postoperative Care

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Yang, MD; Phone Number: +8613810655237; Email: yangming@cicams.ac.cn

Study Locations

• China
  • PUMC
    • Beijing, PUMC, China, 10010
      • Recruiting
      • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Ming Yang, MD; Phone Number: +8613810655237; Email: yangming@cicams.ac.cn
      • Contact: Fengchun Mu; Phone Number: 18888294650; Email: alicemfc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Risk: ML-Based Intervention; This is the High-Risk Intervention Group. Patients identified as high-risk for SSI (predicted probability ≥ 50%) by the LightGBM model within 72 hours post-surgery receive an enhanced, individualized intervention package, which may include an escalated antibiotic regimen, intensified nutritional support, and closer monitoring.	Other: ML-Based Enhanced Intervention Package for SSI Prevention; This is a comprehensive, individualized intervention package administered to patients identified as high-risk for surgical site infection (SSI) by a machine learning (LightGBM) model. The package is activated postoperatively and may include, but is not limited to: 1) **Escalated/optimized antibiotic prophylaxis regimen**; 2) **Intensified nutritional support protocols**; 3) **Enhanced monitoring** of vital signs and wound status. The specific components are tailored based on the patient's risk profile and clinical context. The intervention aims to validate the effectiveness of a model-driven strategy in reducing SSI incidence.
Active Comparator: Low-Risk: Standard Care; This is the Low-Risk Routine Care Group. Patients identified as low-risk for SSI (predicted probability < 50%) by the same model receive the current standard postoperative care of the hospital, following established clinical pathways without the enhanced intervention package. This arm serves as the control.	Other: Standard Postoperative Care; This intervention represents the current standard of care provided to patients after elective central nervous system tumor surgery at this institution. It includes routine antibiotic prophylaxis, standard wound care, basic vital signs monitoring, and follow-up according to established clinical pathways. Patients in this group do not receive the enhanced, study-specific intervention package and serve as the control population for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site infection within 90 days postoperatively	The occurrence of a surgical site infection (SSI) following central nervous system tumor surgery, diagnosed according to the U.S. National Healthcare Safety Network (NHSN) criteria. Diagnosis will be adjudicated by a blinded independent endpoint adjudication committee.	90 days post-surgery

Collaborators and Investigators

• Sponsor: Ming Yang

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: machine learning; surgical site infection; central nervous system tumor; clinical decision support system; explainable artificial intelligence; SHAP
• Additional Relevant MeSH Terms: Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Infections; Nervous System Neoplasms; Wound Infection; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Surgical Wound Infection
• Other Study ID Numbers: NCC2025-CNS-SSI; 2024-I2M-3-014 (Other Grant/Funding Number: CAMS Innovation Fund for Medical Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in this article (including demographics, clinical characteristics, model input variables, and primary endpoint) will be shared. The study protocol, statistical analysis plan, and informed consent form will also be made available. Data will become available following publication of the primary results in a peer-reviewed journal and will be accessible for at least 5 years. Access will be granted to researchers whose methodologically sound proposals have been approved by a scientific review committee, via a controlled-access data repository or upon request.
• IPD Sharing Time Frame: The de-identified IPD and supporting documents will become available no later than 6 months after the publication of the primary study findings in a peer-reviewed journal. The data will be accessible for a minimum of 5 years thereafter.
• IPD Sharing Access Criteria: Access to IPD will be granted to qualified researchers for legitimate scientific research purposes. Requestors must submit a methodologically sound research proposal to the study Principal Investigator (PI) for review by a designated scientific committee. Proposals will be evaluated for scientific merit, feasibility, and ethical compliance. Data requestors will be required to sign a data use agreement (DUA) prohibiting re-identification attempts, unauthorized redistribution, and commercial use.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No