Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculopeā¦ (NCT07547826) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
Egypt164 participantsStarted 2026-05
Plain-language summary
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
Who can participate
Age range1 Day ā 18 Years
SexALL
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Inclusion Criteria:
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 Criteria:
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 ā¦
What they're measuring
1
Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections