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IRCT20211023052845N1 IRCT 2021-12-20 Esfahan University of Medical Sciences Evaluation of the effect of vancomycin and betadine on wound infection The Effect of of Vancomycin powder and Povidon-Iodine in the Prevention of Wound infection in Open Lower-limb Fractures Undergoing Open Reduction and Internal Fixation 2021-11-22 anticipated 40 Complete https://irct.ir/trial/59556 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: Simple randomization The method of assigning people to two groups of control and intervention will be so that the researcher uses a random table of numbers. This table contains a set of masses of numbers that are produced without a specific pattern or order and completely randomly and It is shown as a table. The researcher will consider two columns A (intervention) and B (control). After that the researcher touches one of the table numbers randomly and without looking at the table. If the even number is placed under the finger, the even sample will be considered for column A (intervention group) and if the odd number is placed, will be considered for column B (control group). Until it reaches the desired sample size in each group, Blinding description: completely, the purpose of the study will be explained to patients, and if they are satisfied, those who have criteria for entering and answer positively to the research proposal will enter the study. All patients will be explained how to intervene, but patients will have no information about whether they will be allocated in the control or intervention group, and after sampling and analyzing the data, Information is given for both groups to performance of ethic of research (single blind). The intervention is performed by the researcher but randomization of people is done by the researcher, expert colleague to determine the control group or intervention and the researcher is unaware of the process until the end of the sampling stage. Before the researcher enters the operation field, the solution, will be provided by the research colleague. It should be noted that Poidon Aidan solution alone, have the same color and odor as well as the combination of betadine and vancomycin, , and experiments have confirmed this (double-blind). The statistical analyzer and the data safety and monitoring committee have no information about which data belongs to which control or intervention group, and only the checklist that filled by the researcher during the evaluation and analysis of the data is provided to them (triple-blind). N/A Open Fractures in Limbs. Intervention 1: In the intervention group, after primary skin prep with betadine 7%, for secondary prep, 10% betadine solution with vancomycin powder in the amount of 2 g is used and it will be done using 3 sterile sponge. Intervention 2: Control group: Control group: In the control group, after primary skin prep with betadine 7%, for secondary prep, betadine 10% alone (routine method) is used using 3 sterile gases. No - There is not a plan to make this available Justification or reason for not sharing IPD is Published with the necessary coordination
public Yaser Abolhasani Heydarabad
No.24, Shahidan Abdolahi, Shahid Hoseini Blvd
Rafsanjan Iran (Islamic Republic of) 7719678396 +98 34 3422 5147 yaserabolhasani@yahoo.co.uk Esfahan University of Medical Sciences scientific Soheila Bakhtiari
Hezar jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7510 bakhtiari@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of open fracture and the need for open reduction and internal fixation surgery The patient should not be referred to the operating room as a vital emergency and should be fasted for 8 hours before the operation Age between 18 and 65 years Having a body mass index between 18 and 25 Not pregnant during the study Lack of sensitivity to seafood No autoimmune diseases and immune system defects (Guillain-Barre, multiple sclerosis, immune deficiency syndrome, etc.) Not having any declining bone disease Do not take antibiotics one week before surgery No skin diseases No history of orthopedic and neurosurgery during the last 6 months Absence of cIII degree open fractures in Gastillo Anderson classification No smoking and drug addiction Lack of underlying and autoimmune diseases (diabetes, multiple sclerosis, immune deficiency syndrome, etc.) No previous allergy to antibiotics and disinfectants Informed consent 18 years 65 years Both Intraoperative blood transfusion Unforeseen events before surgery such as cardiac arrest and death Patient death during study (within 30 days after surgery) Bleeding more than 200 cc Duration of surgery more than 2 hours Arbitrary use of antibiotics without a doctor's prescription The interval between going to the emergency room and surgery is more than 23 hours Reluctance to continue participating in research T14.8 Injury of unspecified body region Prevention Prevention In the intervention group, after primary skin prep with betadine 7%, for secondary prep, 10% betadine solution with vancomycin powder in the amount of 2 g is used and it will be done using 3 sterile sponge. Control group: Control group: In the control group, after primary skin prep with betadine 7%, for secondary prep, betadine 10% alone (routine method) is used using 3 sterile gases. Infection. Timepoint: The first, second, fourteenth and twenty-eighth days after surgery. Method of measurement: Visual scale analog and laboratory sampling. Esfahan University of Medical Sciences Approved 2021-10-20 کمیته اخلاق دانشگاه علوم پزشکی اصفهان Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)