]>
IRCT20180826040869N1 IRCT 2018-09-25 Mazandaran University of Medical Sciences The effectiveness of local vancomycin powder in the prevention of surgical site infections in posterior spinal surgeries The effectiveness of local vancomycin powder in the prevention of surgical site infections in posterior spinal surgeries 2016-06-08 anticipated 200 Complete https://irct.ir/trial/33546 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The referral who will be admitted to the study will be selected based on Comorbid conditions, including the presence or absence of diabetes, and the timing of the matching procedure. Each person is given a code and using the table. Random numbers are divided into two groups of 100 on the conditions of comorbid conditions including the presence or absence of diabetes and the time of matching surgery ) Takes place, Blinding description: After selecting the samples, the patients were randomly assigned to the two groups by randomization. One group received vancomycin and the control group who received only prophylaxis (intravenous only intravenous cesophageal) and another evaluated the surgical site. N/A Lumbar spinal cord stenosis- vertebral instability- DJD changes- -spinal trauma candidates candidate- surgery for decompression of the spinal cord - spinal fusion. Intervention 1: In the intervention group, on the day of preoperative surgery, one gram of intravenous cefazolin is used at the end of the surgery before closing the wound with 1 g of vancomycin powder locally in the wounds below 10 cm and 5.1 g for wounds greater than 10 cm. All Patients will be screened again for two weeks, one month and two months after the operation, and the condition of the wound will be investigated for infection. In cases of suspected surgery site infection, including the secretion and opening of the wound, the cultures of the site will be used to confirm the presence of the infection. ESR and CRP are also checked. Intervention 2: Control group: In the control group, only the patient will receive an antibiotic prophylaxis (1 g of venous cefazolin) before surgery, and as an interventional surgical wound for two weeks, one and two months later, the infection will be monitored. 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 "No more information"
public Misagh Shafizad
Amir Mazandrani Blvd, Sari Town
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 mi.shafizad@gmail.com Mazandaran University of Medical Sciences scientific Misagh Shafizad
Amir Mazandarani Blvd ,Sari Town
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 mi.shafizad@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Spinal cord stenosis Vertical instability DJD changes Spinal trauma Age between 18 and 85 years 18 years 85 years Both Dora tear during surgery Revision operation Age under 18 and over 85 years Chronic renal failure Taking corticosteroids and immunosuppressive drugs Diabetes mellitus M99.3 Osseous stenosis of neural canal Treatment - Drugs Treatment - Drugs In the intervention group, on the day of preoperative surgery, one gram of intravenous cefazolin is used at the end of the surgery before closing the wound with 1 g of vancomycin powder locally in the wounds below 10 cm and 5.1 g for wounds greater than 10 cm. All Patients will be screened again for two weeks, one month and two months after the operation, and the condition of the wound will be investigated for infection. In cases of suspected surgery site infection, including the secretion and opening of the wound, the cultures of the site will be used to confirm the presence of the infection. ESR and CRP are also checked. Control group: In the control group, only the patient will receive an antibiotic prophylaxis (1 g of venous cefazolin) before surgery, and as an interventional surgical wound for two weeks, one and two months later, the infection will be monitored. Percentage of people who have a surgical wound infection. Timepoint: Patients will be screened for infection two weeks, one month and two months after surgery. Method of measurement: An infection site of the surgery, including the secretion and opening of the wound, from the cultures of the site of the operation to confirm the presence of the infection will be used. The ESR test also has a positive CRP.wound, will be used to determine the presence of the infection. Mazandaran University of Medical Sciences Approved 2016-10-06 Ethics committee of Mazandaran University of Medical Sciences Amir mazandrani Blvd sari Town Sari Mazandaran Iran (Islamic Republic of)