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HydrocephalusPhase 4NCT07547826

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

A Phase 4 study testing Topical Vancomycin Powder and Standard Perioperative Care in people with Hydrocephalus and Ventriculoperitoneal Shunt Infection, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 day to 18 years
What is being tested?
Topical Vancomycin Powder and Standard Perioperative Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteEgypt
Study dates
May 2026to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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."

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Romany Naguib Said, MBBCh contact

+201202700744

romany.17289966@med.aun.edu.eg

Mahmoud H Ragab, MD contact

+201004001789

ragabm@aun.edu.eg

Egypt1 site

  • Assiut University, Faculty of Medicine, Assiut University Hospitals, Department of Neurosurgery

    Asyut, Asyut Governorate, 71515

    Romany Naguib Said, MBBCh, +201202700744, romany.17289966@med.aun.edu.eg

    Mahmoud Hassan Ragab, MD, +201004001789, ragabm@aun.edu.eg

Other trials in Egypt

About this study

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
Read the 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.

Being tested
Topical Vancomycin Powder, Standard Perioperative Care
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
Medical subject headings
Hydrocephalus, Surgical Wound Infection, Postoperative Complications, Prosthesis-Related Infections, Bacterial Infections and Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical Vancomycin PowderDrug

    Also called Vancomycin Hydrochloride, TVP

    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.
    1. Application Technique (The "Dusting" Method) The application will follow a systematic "dusting" protocol to achieve a high

  • Standard Perioperative CareProcedure or surgery

    "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."

Study groups in NCT07547826
Study groupRoleWhat they receive
Topical Vancomycin Powder (TVP) GroupExperimentalPatients 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.
Receives: Drug: Topical Vancomycin Powder; Procedure: Standard Perioperative Care
Control GroupActive comparatorPatients 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.
Receives: Procedure: Standard Perioperative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Within 6 months postoperatively.

Secondary outcomes (4)

  1. 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.

    Measured: Up to 6 months postoperatively

  2. 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."

    Measured: Up to 6 months postoperatively.

  3. 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.

    Measured: At the time of infection diagnosis (within 6 months postoperatively).

  4. 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. *

    Measured: Up to 6 months postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547826
Sponsor's protocol ID
AUN-NS-2026-RN
Status last verified
Apr 2026
First submitted
17 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23622935

  • Kahle KT, Kulkarni AV, Limbrick DD Jr, Warf BC. Hydrocephalus in children. Lancet. 2016 Feb 20;387(10020):788-99. doi: 10.1016/S0140-6736(15)60694-8. Epub 2015 Aug 6.

    PubMed 26256071

  • Javeed F, Mohan A, Wara UU, Rehman L, Khan M. Ventriculoperitoneal Shunt Surgery for Hydrocephalus: One of the Common Neurosurgical Procedures and Its Related Problems. Cureus. 2023 Feb 15;15(2):e35002. doi: 10.7759/cureus.35002. eCollection 2023 Feb.

    PubMed 36938269

  • Grosfeld JL, Cooney DR. Inguinal hernia after ventriculoperitoneal shunt for hydrocephalus. J Pediatr Surg. 1974 Jun;9(3):311-5. doi: 10.1016/s0022-3468(74)80286-1. No abstract available.

    PubMed 4843985

  • Kuruoglu T, Altun G, Kuruoglu E, Turan DB, Onger ME. Actions of N-acetylcysteine, daptomycin, vancomycin, and linezolid on methicillin-resistant Staphylococcus aureus biofilms in the ventriculoperitoneal shunt infections: an experimental study. Chin Neurosurg J. 2022 Jul 5;8(1):15. doi: 10.1186/s41016-022-00284-2.

    PubMed 35791005

  • Bayston R, Ashraf W, Bhundia C. Mode of action of an antimicrobial biomaterial for use in hydrocephalus shunts. J Antimicrob Chemother. 2004 May;53(5):778-82. doi: 10.1093/jac/dkh183. Epub 2004 Mar 31.

    PubMed 15056650

  • Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med. 2004 Apr 1;350(14):1422-9. doi: 10.1056/NEJMra035415. No abstract available.

    PubMed 15070792

  • Hasanpour M, Rezaee H, Samini F, Keykhosravi E. Effects of Intraventricular Vancomycin Administration on the Prevention of Ventricular Shunt Infection. J Neurol Surg A Cent Eur Neurosurg. 2023 Jun 1. doi: 10.1055/a-2104-1461. Online ahead of print.

    PubMed 37263286

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topical Vancomycin Powder and Standard Perioperative Care in people with Hydrocephalus and Ventriculoperitoneal Shunt Infection, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Romany Naguib Said, MBBCh (+201202700744, romany.17289966@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Ventriculoperitoneal (VP) Shunt Infections (time frame: Within 6 months postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547826, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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