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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Topical Vancomycin Powder

    Drug

    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

    Procedure/Surgery

    "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."

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Topical Vancomycin Powder (TVP) GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections

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).

Time frame
Within 6 months postoperatively.

Secondary outcomes

1

Efficacy Analysis Stratified by Hydrocephalus Etiology

To evaluate and compare the prophylactic efficacy of topical vancomycin powder across distinct etiological subgroups, specifically congenital, post-inflammatory, and post-hemorrhagic hydrocephalus. This analysis aims to determine if the "depot effect" of the powder varies based on the underlying cause of hydrocephalus.

Time frame
Up to 6 months postoperatively
2

Time-to-Infection (Shunt Survival Rate).

Shunt 'infection-free survival' will be compared between the intervention and control groups using Kaplan-Meier survival curves. The statistical significance of differences in survival distribution between the two arms will be assessed using the Log-rank (Mantel-Cox) test. Time-to-infection will be calculated from the date of the index surgery to the date of confirmed diagnosis of infection."

Time frame
Up to 6 months postoperatively.
3

Microbiological Profile of Infected Shunts.

Identification of the causative bacterial species (e.g., Coagulase-negative Staphylococci, S. aureus, Gram-negative bacilli) in failed cases through culture and sensitivity testing of CSF and wound swabs.

Time frame
At the time of infection diagnosis (within 6 months postoperatively).
4

Cost-Effectiveness Analysis of Topical Vancomycin Powder.

The cost-effectiveness of using topical Vancomycin powder will be calculated using the Incremental Cost-Effectiveness Ratio (ICER) according to the following formula: ICER = (Cost\_Vancomycin - Cost\_Control) / (Effect\_Vancomycin - Effect\_Control) \*Where "Cost" represents the total direct medical costs (shunt hardware, drug cost, and management of complications), and "Effect" represents the infection-free rate in each group. \*

Time frame
Up to 6 months postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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