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Clinical Trials in Egypt / NCT07547826
Starting soon Phase 4

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

NCT07547826 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Phase 4
Started
2026-05
Last updated
2026-04-23

Condition(s) studied

HydrocephalusVentriculoperitoneal Shunt InfectionSurgical Site Infection (SSI)Cerebrospinal Fluid Shunt InfectionPediatric HydrocephalusHydrocephalus in ChildrenHydrocephalus in InfantsPostoperative ComplicationsProsthesis-Related InfectionsBacterial Infections and Mycoses

Investigational drug(s) / intervention(s)

Topical Vancomycin Powder →Standard Perioperative Care

Topical Vancomycin Powder: Intraoperative Topical Vancomycin Application 1. Preparation and Material Pure vancomycin hydrochloride powder, sourced from conventional vials intended for intravenous reconstitution, will be utilized. The vials shall be opened under strictly sterile conditions within the operative field immediately prior to wound closure to ensure maximum potency and sterility. 2. Dosage Stratification To ensure therapeutic efficacy while maintaining a high safety profile, the dosage is stratified based on the patient's age and anatomical considerations: * Older Children (1 to 18 years): A standardized dose of 1 gram (1000 mg) will be applied. * Infants and Neonates (under 1 year): A weight-adjusted or reduced dose of 500 mg (0.5 grams) will be administered to accommodate the limited subgaleal and subcutaneous volume and to prevent potential local tissue irritation. 3. Application Technique (The "Dusting" Method) The application will follow a systematic "dusting" protocol to achieve a high

Standard Perioperative Care: "Patients receive the standard institutional protocol for VP shunt insertion, which includes preoperative and postoperative intravenous antibiotic prophylaxis and standard surgical technique without the application of topical antibiotic powder."

Study 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

Eligibility

Sex
ALL
Min age
1 Day
Max age
18 Years
Healthy volunteers
No
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 prolonged operative time as a confounding risk factor for infection."

Primary outcome measure(s)

  • Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections — Within 6 months postoperatively.
    Evaluation of the efficacy of intraoperative topical Vancomycin powder in reducing the overall rate of shunt-related infections. Shunt infection will be defined based on: 1. Clinical signs (wound discharge, erythema, or peritonitis). 2. Laboratory findings (Positive CSF culture or abnormal CSF biochemistry). 3. radiological evidence of shunt failure 4. Surgical evidence (purulence during revision).

Trial sites (1)

FacilityCityRegionStatus
Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery Asyut Asyut Governorate

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Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH Starting soon
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Other trials for the same condition

Intraoperative Fluid Management Guided by Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries Recruiting
Efficacy of Local Gentamicin Containing Collagen In Prevention of Post Stermotomy Infection In Cardiac Surgery Active, not recruiting
Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section Recruiting
Role of Endoscopic Third Ventriculostomy Imanagement of Hydrocephalus in Pediatric Age Group; Clinical and Surgical Outcome Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07547826 on ClinicalTrials.gov ↗ ← All trials in Egypt