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IRCT20210510051242N1 IRCT 2021-06-27 Mashhad University of Medical Sciences Effect of antibiotic after septoplasty Effect of antibiotic and application on septalmucosal outcome afterseptoplasty 2021-05-22 anticipated 90 Complete https://irct.ir/trial/56170 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: 90 patients are considered as candidates for septoplasty due to septal deviation and nasal obstruction. During the operation, patients who need splints at the surgeon's discretion are considered as a study group and splints are used and after surgery. For this group of oral antibiotics, 500 mg cephalexin capsules are prescribed. Other patients for whom splints have not been used during surgery are assigned to two groups using a random number table. For one group of oral antibiotics, 500 mg of cephalexin capsules are prescribed, and for the control group, according to the opinion of a pharmacist, placebo is used instead of antibiotics. The placebo used is the cocci-ten di-vitamin capsule, which is similar to how antibiotics are used for patients in the treatment group. The placebo used was prepared in collaboration with the pharmaceutical group with a similar appearance to the antibiotic used, which has a complementary aspect and this drug does not have any therapeutic properties. Medications will be given as capsules to patients one hour before surgery .All study groups were generally introduced and explained to the patient , Thus, in case of a faulty injury, a splint needs to be implanted and due to the splint, antibiotics are prescribed, and in case of complete mucosal health and no need to implant a splint, patients in both groups should be prescribed antibiotics and no antibiotics should be prescribed to determine the need. To the drug, in cases where there is no need to implant a split in the healthy mucosa And while the patient agrees to be in one of the groups, with the discretion of the physician while obtaining the written and inserted informed consent, they enter the study . Therefore, due to the nature of the study, the physician in charge of surgery will be aware of the allocation of splints to patients, but patients will not be aware of the use of splints or the type of drug used. N/A Septal deviation. Intervention 1: Intervention group: After septal surgery without splinting, they receive 500 mg of cephalexin oral antibiotic every 6 hours. After surgery and two weeks after the visit, the septum mucosa is cultured. And bacterial growth is compared in two culture media. Intervention 2: Intervention group: The group that is used after splint surgery and receives antibiotics. It is cultured after surgery and two weeks after the visit and removal of the splint from the septal mucosa. And bacterial growth is compared in two culture media. Intervention 3: Control group: Patients who do not receive antibiotics after splint surgery and a culture sample is taken from the septal mucosa after surgery and two weeks after the visit. And bacterial growth is compared in two culture media. 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 more information
public Bashir Rasoulian
ENT Center Group ,Qaem Hosp, Shariati Squ.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 rasoulianb@mums.ac.ir Mashhad University of Medical Sciences scientific Bashir Rasoulian
ENT Center Group ,Qaem Hosp, Shariati Squ.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 rasoulianb@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Negative history of sinus and nasal surgery No immunodeficiency disease 18 years 65 years Both No cpration of patient Infection symptom before surgery Reciving antibiotics before surgery Reciving antibiotic 20 days before Cardiovascular risk factor J34.2 Deviated nasal septum Treatment - Drugs Treatment - Drugs N/A Intervention group: After septal surgery without splinting, they receive 500 mg of cephalexin oral antibiotic every 6 hours. After surgery and two weeks after the visit, the septum mucosa is cultured. And bacterial growth is compared in two culture media. Intervention group: The group that is used after splint surgery and receives antibiotics. It is cultured after surgery and two weeks after the visit and removal of the splint from the septal mucosa. And bacterial growth is compared in two culture media. Control group: Patients who do not receive antibiotics after splint surgery and a culture sample is taken from the septal mucosa after surgery and two weeks after the visit. And bacterial growth is compared in two culture media Mucosal culture after septoplasty. Timepoint: After surgery and 2 weeks later. Method of measurement: Bacterial culture medium. Mashhad University of Medical Sciences Approved 2020-04-18 Ethics committee of Mashhad University of Medical Sciences Azadi squ . Eastern door of pardis uni . Medical uni Mashhad Razavi Khorasan Iran (Islamic Republic of)