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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Topical Vancomycin Powder
  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 o
• Процедура Standard Perioperative Care
  "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."

Первичные конечные точки

• Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections [Срок оценки: Within 6 months postoperatively.]

Вторичные конечные точки (4)

• Efficacy Analysis Stratified by Hydrocephalus Etiology [Срок оценки: Up to 6 months postoperatively]
• Time-to-Infection (Shunt Survival Rate). [Срок оценки: Up to 6 months postoperatively.]
• Microbiological Profile of Infected Shunts. [Срок оценки: At the time of infection diagnosis (within 6 months postoperatively).]
• Cost-Effectiveness Analysis of Topical Vancomycin Powder. [Срок оценки: Up to 6 months postoperatively.]

Критерии участия

Критерии включения

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.

Критерии исключения

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."

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosu — Asyut

Публикации

• Xu SJ, Liu XL, Shi JP, Shi JX. The Effect of Topical Vancomycin Powder Application on the Rate of Intervertebral Fusion Following Lumbar Fusion: A Retrospective Study. World Neurosurg. 2024 May;185:e1216-e1223. doi: 10.1016/j.wneu.2024.03.059. Epub 2024 Mar 20. PMID 38514028
• Khunchamnan S, Sopchokchai I, Sawanyawisuth K, Kitkhuandee A. An Antibiotic Prophylaxis for Prevention of Ventriculoperitoneal Shunt Infection Using Intraventricular Injection and Shunt Soaking with Vancomycin and Gentamicin. Antibiotics (Basel). 2026 Jan 5;15(1):60. doi: 10.3390/antibiotics15010060. PMID 41594097
• Abdullah KG, Chen HI, Lucas TH. Safety of topical vancomycin powder in neurosurgery. Surg Neurol Int. 2016 Dec 5;7(Suppl 39):S919-S926. doi: 10.4103/2152-7806.195227. eCollection 2016. PMID 28031984
• Ho AL, Cannon JGD, Mohole J, Pendharkar AV, Sussman ES, Li G, Edwards MSB, Cheshier SH, Grant GA. Topical vancomycin surgical prophylaxis in pediatric open craniotomies: an institutional experience. J Neurosurg Pediatr. 2018 Dec 1;22(6):710-715. doi: 10.3171/2018.5.PEDS17719. Epub 2018 Aug 24. PMID 30141749
• Youn SB, Hwang G, Kim HG, Kang JS, Kim HC, Oh SH, Kim MK, Chung BS, Rhim JK, Sheen SH. Intrawound Vancomycin Powder Application for Preventing Surgical Site Infection Following Cranioplasty. J Korean Neurosurg Soc. 2023 Sep;66(5):536-542. doi: 10.3340/jkns.2023.0024. Epub 2023 Apr 10. PMID 37032483
• Krause M, Mahr CV, Schob S, Nestler U, Wachowiak R. Topical instillation of vancomycin lowers the rate of CSF shunt infections in children. Childs Nerv Syst. 2019 Jul;35(7):1155-1157. doi: 10.1007/s00381-019-04185-1. Epub 2019 May 20. PMID 31111179
• Peng Z, Lin X, Kuang X, Teng Z, Lu S. The application of topical vancomycin powder for the prevention of surgical site infections in primary total hip and knee arthroplasty: A meta-analysis. Orthop Traumatol Surg Res. 2021 Jun;107(4):102741. doi: 10.1016/j.otsr.2020.09.006. Epub 2020 Nov 27. PMID 33257290
• Strom RG, Pacione D, Kalhorn SP, Frempong-Boadu AK. Lumbar laminectomy and fusion with routine local application of vancomycin powder: decreased infection rate in instrumented and non-instrumented cases. Clin Neurol Neurosurg. 2013 Sep;115(9):1766-9. doi: 10.1016/j.clineuro.2013.04.005. Epub 2013 Apr 23. PMID 23622935

Идентификаторы

NCT: NCT07547826 · AUN-NS-2026-RN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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