An interventional study of ML-Based Enhanced Intervention Package for SSI Prevention and Standard Postoperative Care in Surgical Site Infection (SSI) and Central Nervous System Tumor, sponsored by Ming Yang. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Ming Yang · Not applicable, Interventional, and Diagnostic
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.
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.
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.)
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.
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
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Ming Yang is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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.
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.
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.
Time frame: 90 days post-surgery
Plan to share: Yes — 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.
Supporting information: Analytic code
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ming Yang