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IRCT20240814062757N1 IRCT 2024-12-03 Mashhad University of Medical Sciences Evaluation of the effect of local wound irrigation on reduction shunt infection - Evaluation of the effect of local wound irrigation with vancomycin on reduction shunt infection in children with hydrocephalus 2024-12-21 anticipated 143 Complete https://irct.ir/trial/78704 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Hydrocephalus. Intervention 1: A vial of vancomycin mixed with normal saline solution is added to 5 cc and 2.5 cc of the above solution is washed in the head incision site and 2.5 cc in the abdominal incision site. Intervention 2: Local irrigation of the incision site of the head and abdomen with normal saline. Yes - There is a plan to make this available What will be shared: 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. When: Access after printing the results To whom: Researchers working in scientific and academic institutions Conditions: Non-identifiable data of individuals will be made available for use in relevant research and to check the accuracy of study results. Where to obtain: To receive data, contact the corresponding author via email. How to obtain: 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. Comments:
public Marzieh Maleki
No. 206, Between 14 and 16 Hemmat Alley, Beheshti Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9175743154 +98 51 3871 3801 malekim991@mums.ac.ir Mashhad University of Medical Sciences scientific Marzieh Maleki
No. 206, Between 14 and 16 Hemmat Alley, Beheshti Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9175743154 +98 51 3871 3801 malekim991@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children under 15 years of age with definitive diagnosis of hydrocephalus who are candidates for ventriculoperitoneal shunt surgery. 1 day 15 years Both Previous history of meningitis or shunt infection Any surgery in the CNS system in the last 3 months before shunt insertion or 6 months after shunt insertion Any dysfunction of the immune system, history of repeated CSF drainage in the last 3 months (ventricle tap, LP, EVD) History of any abdominal surgery in the last 3 months Lack of available data in terms of study variables or exclusion criteria, any manipulation including revision or shunt tap within 6 months after shunt insertion. G91.9 Hydrocephalus, unspecified Prevention Placebo A vial of vancomycin mixed with normal saline solution is added to 5 cc and 2.5 cc of the above solution is washed in the head incision site and 2.5 cc in the abdominal incision site. Local irrigation of the incision site of the head and abdomen with normal saline Percentage of patients with shunt infection. Timepoint: Specialist visit in 3 months after shunt insertion. Method of measurement: Examination by a neurosurgeon. Mashhad University of Medical Sciences Approved 2024-07-23 Ethics Committee of School of Medicine, Mashhad University of Medical Sciences Shahid Fakuri Blvd., Knowledge and Health Borough, Central Organization of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)