]>
IRCT20210712051848N1 IRCT 2021-08-13 Shahid Beheshti University of Medical Sciences The efficacy of local vancomycin on postoperative infection Local Vancomycin Therapy to Reduce Surgical Site Infection in Spine Surgery: A Randomized Prospective Study 2019-09-01 anticipated 360 Complete https://irct.ir/trial/57511 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the web-based randomization method is used. The individual randomization unit is a sealed envelope randomization tool, and the samples are randomly divided into 2 groups with equal numbers. www.Randomization.com is used to random allocation. The method of Sequentially numbered, sealed, opaque envelopes is used for allocation concealment, Blinding description: The patient participating in the study is not aware of her/his group and due to the fact that vancomycin powder is used under anesthesia, there is no need to use a placebo. 3 Surgical site infections. Intervention 1: Intervention group: after surgery and irrigation with normal saline, vancomycin powder is used locally in the intervention group. If the level to be operated is one level, one gram is used and if it is more than one level, two grams of vancomycin are used. The vancomycin used is made by Exir Pharmaceutical Company and it is used on muscles, subcutaneous tissue and fascia. The skin and fascia are then repaired. Intervention 2: Local drug or placebo is not used. After surgery, the operation site is irrigated with normal saline and the fascia, muscles and skin are closed in several layers. Yes - There is a plan to make this available What will be shared: The study data is shared at the request of researchers after deleting personal details and identifying individuals When: Access to data starts from the time the results are published. To whom: Data will be sent to all researchers who request it Conditions: The use of the requested data for meta-analysis is permitted in systematic review studies Where to obtain: Researchers can contact Dr. Hamid Reza Khayat Kashani for the data in the following ways:Email: hrkhka@gmail.com Tel: 00989131625625 Address: Neurosurgery Department,Imam Hosein Hospital, Madani Street, Tehran, Iran How to obtain: After the researcher's request to receive the data, it is referred to the research deputy of the neurosurgery department, and after reviewing the researcher's profile and his request on how to use the data, if agreed, the data will be sent to him or her. Otherwise, he/she will be informed of the reason for not sending the data, and this process will take less than a month. Comments:
public Hamid Reza Khayat Kashani
Imam Hossein Hospital, Shahid Madani St., Imam Hossein Square
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 hrkhka@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamid Reza Khayat Kashani
Imam Hossein Hospital, Shahid Madani St., Imam Hossein Square
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 hrkhka@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age who underwent open spinal surgery in the cervical, thoracic and lumbosacral regions 18 years no limit Both Previous history of spine infection History of immunodeficiency or ongoing chemotherapy History of kidney or liver failure Allergy to vancomycin or cephalosporin Inability to follow up to 3 months after surgery Primary or metastatic spinal cord or spine tumors Dissatisfaction with the study. T84.6 Infection and inflammatory reaction due to internal fixation device [any site] Treatment - Drugs Treatment - Drugs Intervention group: after surgery and irrigation with normal saline, vancomycin powder is used locally in the intervention group. If the level to be operated is one level, one gram is used and if it is more than one level, two grams of vancomycin are used. The vancomycin used is made by Exir Pharmaceutical Company and it is used on muscles, subcutaneous tissue and fascia. The skin and fascia are then repaired. Local drug or placebo is not used. After surgery, the operation site is irrigated with normal saline and the fascia, muscles and skin are closed in several layers. Discharge from the wound. Timepoint: The wound site is examined at the time of discharge, two weeks after surgery, and 3 months after surgery. Method of measurement: Physical examination and history. Swelling of the operation site. Timepoint: The wound site is examined at the time of discharge, two weeks after surgery, and 3 months after surgery. Method of measurement: Physical examination and history. Redness of the operation site. Timepoint: The wound site is examined at the time of discharge, two weeks after surgery, and 3 months after surgery. Method of measurement: Physical examination and history. Shahid Beheshti University of Medical Sciences Approved 2019-08-27 Ethics Committee of Medical School, Shahid Beheshti University of Medical Sciences School of Medicine, Shahid Beheshti University of Medical Sciences, Koodkiar St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)