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IRCT2015041521787N1 IRCT 2015-09-14 Vice chancellor for research, Tehran University of Medical Sciences The role of antibiotics in mandibular fractures The role of postoperative antibiotics in prevention of infection at open reduction of mandibular compound fractures 2015-09-11 anticipated 75 Complete https://irct.ir/trial/18992 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Mandibular fracture. Intervention 1: Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV were continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups ( antibiotic group and non antibiotic group). The antibiotic group receive 600mg Clindamycin IV tds 7 days postoperative with chlorhexidine gluconate 0.12% oral rinse. The drug company is Dana Tabriz, Iran. Intervention 2: Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV were continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups ( antibiotic group and non antibiotic group). The non Ab group receive placebo drug for 7 days with chlorhexidine gluconate 0.12% oral rinse.
public Dr. Mehrnoush Momeni Rouchi
Dental School of Tehran university of medical science, Hakim street, Kargar street, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8835 1150 m-nobari@student.tums.ac.ir ; minnobari@yahoo.com Tehran university of medical science scientific Dr. Mehrnoush Momeni Rouchi
Tehran university of medical science, Hakim street, Kargar street, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8835 1150 m-nobari@student.tums.ac.ir ; minnobari@yahoo.com Tehran university of medical science Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Open reduction and internal fixation; At least 1 fracture of mandible; Follow up of at least 5 weeks. Exclusion criteria: Infection during surgry; Gunshot wounds; Need for intensive care; Presence of an acute bacterial infection; Pathological fractures; Fracture of the skull base; History of malignancy/ radiation of the head and neck area; Immunosuppression; Reduced body weight; Kidney disease; Inter Maxillary Fixation; Insufficient follow up no limit no limit Both S02.6 Lower jaw (bone) Treatment - Drugs Placebo Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV were continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups ( antibiotic group and non antibiotic group). The antibiotic group receive 600mg Clindamycin IV tds 7 days postoperative with chlorhexidine gluconate 0.12% oral rinse. The drug company is Dana Tabriz, Iran. Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV were continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups ( antibiotic group and non antibiotic group). The non Ab group receive placebo drug for 7 days with chlorhexidine gluconate 0.12% oral rinse. Infection. Timepoint: Follow up appointments were 1,3,5 weeks postoperatively. Method of measurement: Infection, Inflammation, Erythema, Fever, Drainage. Vice chancellor for research, Tehran University of Medical Sciences Approved 2015-06-16 Ethics committee of Tehran university of medical science Ghods central building, Ghods street, Keshavarz street, Tehran, Iran Tehran Iran (Islamic Republic of)