A Phase 4 interventional study of Topical Vancomycin Powder and Standard Perioperative Care in Hydrocephalus, Ventriculoperitoneal Shunt Infection and Surgical Site Infection (SSI), sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Assiut University · Phase 4, Interventional, and Prevention
Objectives
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.
210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.
This study's planned enrollment of 164 is above the median of 50 across 105 interventional studies indexed under Hydrocephalus.
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Patients will be enrolled in the study if they meet all the following criteria:
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:
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.
Drug: Topical Vancomycin Powder · Procedure: Standard Perioperative Care
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.
Procedure: Standard Perioperative Care
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
Also known as: Vancomycin Hydrochloride, TVP
"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."
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.
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
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.
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).
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.
Plan to share: Undecided
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