Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
Key facts
- Where
- Asyut, EgyptSee the site
- Phase
- Phase 4
Where in Egypt
- Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of NeurosurgeryAsyut, EgyptContact: Romany Naguib Said, MBBChNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assiut University
- Trial code
- NCT07547826
- Record updated
- 23 April 2026
- Original description
ObjectivesRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: Revision Surgery: Patients undergoing shunt revision or replacement due to previous infection within the last 3 months; 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."; 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); Hypersensitivity: Known history of allergy to Vancomycin; Local Skin Issues: Active dermatitis or infection at any of the planned incision sites; Active Infection: Clinical or laboratory evidence of systemic sepsis or meningitis at the time of surgery.