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IRCT20120215009014N324 IRCT 2019-12-17 Hamedan University of Medical Sciences Prophylactic effect of cefazolin-vancomycin versus ceftazidime-vancomycin on the infection of surgical site in patients undergoing open heart surgery Prophylactic effect of cefazolin-vancomycin versus ceftazidime-vancomycin on the infection of surgical site in patients undergoing open heart surgery: a double-blind randomized clinical trial 2020-01-05 anticipated 434 Complete https://irct.ir/trial/44192 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The shape of the medications will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 2 Surgical wound infection. Intervention 1: Intervention group: Cefazoline injection 2 to 3 g depending on patient's weight every 6 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours. Intervention 2: Intervention group 2: Ceftazidime injection 1 g every 8 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Soroor Akbari
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 suak1393@gmail.com Hamedan University of Medical Sciences scientific Dr Soroor Akbari
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 suak1393@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 65 years, Indication of open heart surgery. Hospitalization for more than three days 18 years 65 years Both Hemodialysis patients, History of recurrent Freonocellus, Having an artificial valve or vascular graft O86.0 Infection of obstetric surgical wound Treatment - Drugs Treatment - Drugs Intervention group: Cefazoline injection 2 to 3 g depending on patient's weight every 6 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours Intervention group 2: Ceftazidime injection 1 g every 8 hours and vancomycin injection 15 mg/kg every 12 hours for 48 hours Superficial infection at the surgical site. Timepoint: On days 7, 14, 30 and 90 after surgery. Method of measurement: With clinical examination. Hamedan University of Medical Sciences Approved 2019-11-23 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)