Health Trials

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

ConditionsHydrocephalusVentriculoperitoneal Shunt InfectionSurgical Site Infection (SSI)Cerebrospinal Fluid Shunt InfectionPediatric HydrocephalusHydrocephalus in ChildrenHydrocephalus in InfantsPostoperative ComplicationsProsthesis-Related InfectionsBacterial Infections and Mycoses
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-18
SponsorAssiut University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Topical Vancomycin Powder
  • Standard Perioperative Care

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Assiut University

Lead sponsor

Source ClinicalTrials.gov