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

Ventriculoperitoneal (VP) shunt infection remains one of the most formidable challenges in paediatric neurosurgery, with reported incidence rates reaching as high as 11% to 18% in high-volume referral centers (1-5)

These infections lead to catastrophic consequences, including multiple revision surgeries, prolonged hospitalizations, and significant neurodevelopmental morbidity (2,6,7)

Currently, Antibiotic-Impregnated Catheters (AIC) are considered a standard preventive measure in many international guidelines (6,8,9). However, the prohibitive cost and limited accessibility of AICs-especially in resource-limited settings and public healthcare systems-preclude their routine use for every paediatric patient

This economic barrier has necessitated the search for a cost-effective, readily available alternative that provides comparable antimicrobial protection (10-12) Topical Vancomycin Powder (TVP) has emerged as a promising solution.(5,13-16) Unlike systemic prophylaxis, TVP provides an ultra-high local concentration of antibiotics directly at the surgical site, effectively inhibiting biofilm formation-the hallmark of shunt infections (3,17)

Recent high-level evidence has confirmed that TVP is safe for paediatric use, with no reported systemic toxicity or adverse effects on wound healing(18)(19)

While the efficacy of TVP has been observed in various neurosurgical procedures (13-15), there is a lack of prospective, stratified evidence regarding its performance across different hydrocephalus aetiologies when compared to standard non-impregnated shunts.

Most existing literature evaluates vancomycin powder in a generalized cohort. However, post-inflammatory (post-meningitic) and post-hemorrhagic hydrocephalus cases often have a higher baseline risk of infection due to existing CSF changes.

This study uniquely addresses whether the efficacy of topical vancomycin varies across these different etiological strata (congenital - post-inflammatory - post-haemorrhagic hydrocephalus).

Furthermore, clinical outcomes are often confounded by mechanical factors such as distal catheter migration, this study aims to isolate the antimicrobial effect of vancomycin from mechanical shunt failures.

Unlike systemic antibiotics which contribute to global resistance, Topical Vancomycin provides maximal local efficacy with minimal systemic exposure, aligning with modern Antibiotic Stewardship goals to preserve systemic antibiotic potency while protecting surgical hardware (13)(18).

A critical distinction in this study is the use of Vancomycin in its crystalline powder form rather than aqueous irrigation. Comparative studies have demonstrated that while antibiotic irrigation provides a transient clearing of bacteria, it is rapidly absorbed or washed away, failing to maintain the necessary Minimum Inhibitory Concentration (MIC) during the crucial first 24-48 hours of wound healing.

In contrast, Topical Vancomycin Powder (TVP) acts as a sustained-release reservoir, dissolving slowly and maintaining ultra-high local concentrations exactly where the shunt hardware is most vulnerable to biofilm colonization. This 'depot effect' is what gives the powder a superior prophylactic profile over traditional irrigation method.(3)

Therefore, this study aims to evaluate to what extent topical vancomycin powder can effectively reduce infection rates and serve as a financially viable alternative to AICs in the paediatric population.

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."

"To minimize bias, this study employs a double-masking protocol. The Outcome Assessors, responsible for clinical and microbiological diagnosis of shunt infections, are blinded to the treatment allocation. Additionally, the Data Analysts/Statisticians will perform the comparative analysis using coded datasets without knowledge of group assignments. The surgical team (Investigators) cannot be blinded due to the nature of the intervention (topical application of powder). Randomization codes will be secured by a third party and only unblinded after the final statistical analysis is completed."