Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections
研究概览
简要总结
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
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
"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."
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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."
研究组 & 干预措施
Topical Vancomycin Powder (TVP) Group
Patients in this arm will undergo the standard surgical procedure for ventriculoperitoneal (VP) shunt insertion. In addition to standard perioperative intravenous (IV) antibiotic prophylaxis, sterile crystalline Vancomycin powder will be applied directly into Cranial Site (1/3): Around the reservoir and burr hole Tunnel Path (1/3): Dispersed along the subcutaneous track. Abdominal Site (1/3): At the peritoneal entry before closure.
干预措施: Topical Vancomycin Powder (Drug)
Topical Vancomycin Powder (TVP) Group
Patients in this arm will undergo the standard surgical procedure for ventriculoperitoneal (VP) shunt insertion. In addition to standard perioperative intravenous (IV) antibiotic prophylaxis, sterile crystalline Vancomycin powder will be applied directly into Cranial Site (1/3): Around the reservoir and burr hole Tunnel Path (1/3): Dispersed along the subcutaneous track. Abdominal Site (1/3): At the peritoneal entry before closure.
干预措施: Standard Perioperative Care (Procedure)
Control Group
Patients in this arm will undergo the standard surgical procedure for ventriculoperitoneal (VP) shunt insertion with routine perioperative intravenous (IV) antibiotic prophylaxis only. No topical antibiotics will be applied during the procedure.
干预措施: Standard Perioperative Care (Procedure)
结局指标
主要结局
Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections
时间窗: 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).
次要结局
- Efficacy Analysis Stratified by Hydrocephalus Etiology(Up to 6 months postoperatively)
- Time-to-Infection (Shunt Survival Rate).(Up to 6 months postoperatively.)
- Microbiological Profile of Infected Shunts.(At the time of infection diagnosis (within 6 months postoperatively).)
- Cost-Effectiveness Analysis of Topical Vancomycin Powder.(Up to 6 months postoperatively.)
研究者
Romany Naguib Said Boulos
Resident Doctor of Neurosurgery Department , Faculty of Medicine ,Assiut University
Assiut University