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

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

Conditions

• 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

Interventions

DRUG

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

PROCEDURE

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."

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Romany Naguib Said, MBBCh · Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

• Mahmoud H Ragab, MD · Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-05-31

Completion

2027-12-31

Countries

• Egypt

Study Locations