Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies

Starting soon · Phase 4

Conditions studied: Hydrocephalus, Ventriculoperitoneal Shunt Infection, Surgical Site Infection (SSI), Cerebrospinal Fluid Shunt Infection, Pediatric Hydrocephalus, Hydrocephalus in Children, Hydrocephalus in Infants, Postoperative Complications, Prosthesis-Related Infections, Bacterial Infections and Mycoses

In brief

Objectives * Primary: * To measure the reduction in VP shunt infection rates using topical vancomycin powder. * Secondary: * To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory). * To analyze the microbiological profile of failed cases. * To compare the "Time-to-Infection" and shunt survival rates between the study and control groups using Kaplan-Meier analysis. * To evaluate the cost-effectiveness of TVP compared to the standard management and historical AIC data

Key facts

Study ID

NCT07547826

Run by

Assiut University

People needed

164

Starts

2026-05-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-23

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be enrolled in the study if they meet all the following criteria:
• Age Range: Paediatric patients from birth (neonates) up to 18 years of age.
• Indication: Patients undergoing primary (first-time) Ventriculoperitoneal (VP) shunt insertion.
• Aetiology: Hydrocephalus due to congenital causes, post-haemorrhagic, or post-inflammatory origins.
• Consent: Written informed consent provided by the parents or legal guardians.

You may not qualify if…

• To ensure that the infection rate is strictly related to the surgical procedure and not to external chronic factors, patients with the following will be excluded:
• Tumor-related Hydrocephalus: Due to the impact of malignancy, chemotherapy-induced immunosuppression, or potential radiotherapy on wound integrity.
• Co-morbidities: Patients with Diabetes Mellitus, chronic renal failure, or known immunodeficiency disorders (to isolate paediatric physiological response).
• Active Infection: Clinical or laboratory evidence of systemic sepsis or meningitis at the time of surgery.
• Hypersensitivity: Known history of allergy to Vancomycin.
• Revision Surgery: Patients undergoing shunt revision or replacement due to previous infection within the last 3 months.
• Local Skin Issues: Active dermatitis or infection at any of the planned incision sites.
• Complex Hydrocephalus: Patients requiring additional concurrent neurosurgical procedures (e.g., tumor biopsy, Chiari decompression, or cyst fenestration) to avoid prolonged operative time as a confounding risk factor for infection."

Where it is running

• Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery — Asyut, Asyut Governorate, Egypt

Full record on ClinicalTrials.gov

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