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
Conditions
Keywords
Topical Vancomycin Powder, Vancomycin Crystalline Powder, Biofilm Prevention, Ventriculoperitoneal Shunt Infection, Congenital Hydrocephalus, Post-Hemorrhagic Hydrocephalus, Post-Meningitic Hydrocephalus, Cost-Effectiveness, Resource-Limited Settings, Pediatric Neurosurgery, Antibiotic Stewardship, Surgical Site Infection, Antibiotic-Impregnated Catheters, Cerebrospinal Fluid Shunt, Surgical Wound Infection, VP Shunt Infection, AIC
Brief 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
Detailed description
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.
Interventions
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
"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
Study design
Masking description
"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."
Intervention model description
\- Stratification & Block Randomization To ensure a balanced baseline risk, patients will be stratified into three etiologic strata: 1. Stratum 1: Congenital Hydrocephalus. 2. Stratum 2: Post-haemorrhagic Hydrocephalus. 3. Stratum 3: Post-inflammatory (Post-meningitic) Hydrocephalus. Randomization Process: \> Within each stratum, patients will be randomly assigned to either the Control or Vancomycin group in a 1:1 ratio using Permuted Block Randomization. This ensures that at any point during the study, both treatment arms remain balanced across all three aetiologies. . Randomized Interventions * Control Group (50%): Standard perioperative IV antibiotics. * Vancomycin Group (50%): Standard IV antibiotics + Topical Vancomycin Powder. The same type of shunt hardware will be used for all patients in both groups to eliminate manufacturing variability as a confounder.
Eligibility
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."
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Analysis Stratified by Hydrocephalus Etiology | Up to 6 months postoperatively | 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-to-Infection (Shunt Survival Rate). | Up to 6 months postoperatively. | 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." |
| Microbiological Profile of Infected Shunts. | At the time of infection diagnosis (within 6 months postoperatively). | 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. |
| Cost-Effectiveness Analysis of Topical Vancomycin Powder. | Up to 6 months postoperatively. | 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. \* |
Countries
Egypt
Contacts
Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery
Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery