Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculope… (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 range
1 Day – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections