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IRCT20200502047277N10 IRCT 2022-10-03 Shahid Beheshti University of Medical Sciences Povidone iodine-impregnated dressing and surgical site infection in spine surgery Effects of preoperative use of povidone iodine-impregnated dressing on postoperative rate of surgical site infection in patients undergoing posterior lumbar spinal fusion surgery 2022-09-23 anticipated 160 Complete https://irct.ir/trial/63592 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization (1:1) with a block size of 4 will be performed using the SPSS 24, and sealed opaque envelopes will be used for allocation concealment. In SPSS, after dividing the study population into blocks, random numbers between 0 and 1 will be generated for each patient using RV.UNIFORM(0,1) and after determining the rank within each block, the two lower ranks will be assigned to treatment group 1, and the two upper ranks will be assigned to treatment group 2. Except for the surgeon performing the study intervention, patients, principal investigator, outcome assessors, and data analyzers will remain blind to the randomization and allocation. 3 Condition 1: Infection following a procedure. Condition 2: Fusion of spine. Intervention 1: Intervention group: Patients in the study intervention group will receive a sterile gauze soaked in povidone iodine 10% solution, which will be placed over the anticipated incision site 12 hours before the operation. Intervention 2: Control group: Patients in the control group will receive the standard preoperative care with no placebo. 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 There is no further information
public Saeed Oraee Yazdani
Shohadaye Tajrish Hospital, Tajrish Ave.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 saeed_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Roozbeh
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2270 1022 rtavanaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients undergoing posterior lumbar spinal fusion surgery Written informed consent 18 years no limit Both Prior hypersensitivity reaction to study drug Active or history of spinal infection Intradural spinal pathology T81.4 M43.2 Infection following a procedure Fusion of spine Prevention Prevention Intervention group: Patients in the study intervention group will receive a sterile gauze soaked in povidone iodine 10% solution, which will be placed over the anticipated incision site 12 hours before the operation. Control group: Patients in the control group will receive the standard preoperative care with no placebo. Incidence of surgical site infection. Timepoint: During the first postoperative 30 days, including daily during the hospitalization and weekly after discharge. Method of measurement: Physical examination (during the hospitalization) and telephone call (after discharge). Shahid Beheshti University of Medical Sciences Approved 2022-04-24 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)