Evaluation of the effect of local wound irrigation with vancomycin on reduction shunt infection in children with hydrocephalus

Determining the effect of local irrigation with vancomycin in reducing shunt infection in children with hydrocephalus

This study is a randomized double-blind control trial on 143 patients with parallel groups, in 2 control and intervention groups.

Patients admitted to Mashhad Akbar children's hospital will be randomly divided into control and intervention groups. In the intervention group, after fixing the shunt and inserting the catheter and before closing the scalp and abdomen incision site, washing the surgical site with vancomycin (one vial of vancomycin combined with normal saline solution to the amount of 5 cc. 2.5 cc of the above solution will be used for irrigation of the head incision site and 2.5 cc for the abdominal incision site) and in the control group, irrigation will be done only with normal saline.

Inclusion criteria: children under 15 years old with a definitive diagnosis of hydrocephalus, candidates for ventriculoperitoneal shunt surgery. Exclusion criteria: previous history of meningitis or shunt infection, surgery in the CNS system from 3 months before to 6 months after shunt insertion, immune system dysfunction, repeated CSF drainage in the last 3 months (EVD , LP, Ventricular Tap), any abdominal surgery in the last 3 months, lack of available data in terms of study variables or exclusion criteria, any manipulation including shunt revision or tap in 6 months after shunt placement

After catheter insertion and before closing the scalp and abdomen incision sites, irrigation of the surgical site will be done with vancomycin in the intervention group, and with normal saline in the control group.

The rate of shunt infection based on patients' visits to the hospital, hospitalizations and positive culture of cerebrospinal fluid

Blocking will be used for random allocation. Blocks with random sizes will be used. The obtained sequence is only available to the main therapist. Patients and analysts will be unaware of the allocation. Concealment will be done using a closed envelope, patients will receive the envelope on the day of surgery by the researcher and hand it over to the surgeon before surgery.

Concealment will be done using a closed envelope, patients will receive the envelope on the day of surgery by the researcher and hand it over to the surgeon before surgery. In this study, the main researcher knows the grouping of patients (control or intervention group) and delivers the type of grouping to the patients in the form of a closed envelope. Patients hand over the envelope to the professor before surgery. Also, the data analyst is unaware of the grouping of patients

Patient information such as age, sex, head circumference, cause of hydrocephalus, type of shunt used, location of shunt, length of operation, number of surgeons, number of personnel, history of previous shunt, use or non-use of vancomycin solution will be published in a file.

Access after printing the results

Researchers working in scientific and academic institutions

Non-identifiable data of individuals will be made available for use in relevant research and to check the accuracy of study results.

To receive data, contact the corresponding author via email.

The requester must share the reason for the need for the data with the responsible author via email, and the information will be made available at the discretion of the responsible author.