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IRCT20210319050743N1 IRCT 2021-03-24 Zanjan University of Medical Sciences The effect of eliminating antibiotic treatment after appendectomy on surgical site infectionn Efficacy of removing antibiotic therapy after appendectomy in surgical site infection in patients with imperforated appendicitis: A clinical trial 2021-04-04 anticipated 232 Complete https://irct.ir/trial/55149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is block randomization. The size of the blocks is 8 people. Which includes 4 people from the intervention group and 4 people from the control group. The randomization unit is individual. Randomization tool is SAS statistical software. SAS statistical software and PLAN process are used to construct random sequences. For hiding, a random sequence is created first. Then, based on the sample size of the research, a number of envelopes with aluminum wrappers (In order not to see the contents of the envelopes) are prepared. Each random sequence is recorded on a card. The cards are placed in the envelopes of the letters, respectively. In order to maintain a random sequence, envelopes are numbered on the outer surface in the same way. Finally, the envelope lids are glued and placed inside the boxes, respectively, Blinding description: Patients enter the study after obtaining informed written consent. Patients and the health care provider responsible for injecting the drug do not know if the patient is receiving medication or placebo. Also, the outcome assessor does not know at any stage of the examination that the patient initially received medication or placebo. N/A Surgical site infection. Intervention 1: Intervention group: Receive a placebo (distilled water) one cc every 12 hours for 48 hours after surgery. Intervention 2: Control group: They receive one gram of ceftriaxone every 12 hours + 500 mg of metronidazole every 8 hours for up to 48 hours after surgery. 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 Individual and personal data of patients are confidential
public Dr. Mohammad Mohammadi Arbati
Gavazang Road, Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 mohammadarbati@zumc.ac.ir Zanjan University of Medical Sciences scientific Dr. Mohammad Mohammadi Arbati
Gavazang Road, Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 mohammadarbati@zumc.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with acute appendicitis referred to Ayatollah Mousavi Educational and Medical Center in Zanjan no limit no limit Both Immunosuppression in patients undergoing appendectomy Diabetes AIDS Long-term use of corticosteroids Malnutrition Cancer Blood disease with leukocyte insufficiency T81.4 Infection following a procedure Placebo Treatment - Drugs Intervention group: Receive a placebo (distilled water) one cc every 12 hours for 48 hours after surgery Control group: They receive one gram of ceftriaxone every 12 hours + 500 mg of metronidazole every 8 hours for up to 48 hours after surgery. Purulent discharge from the wound. Timepoint: Clinical examination in The end of the first, second and fourth weeks After surgery. Method of measurement: History and clinical examination. Redness and inflammation of the wound. Timepoint: Clinical examination in The end of the first, second and fourth weeks After surgery. Method of measurement: History and clinical examination. Stomach ache. Timepoint: Clinical examination in The end of the first, second and fourth weeks After surgery. Method of measurement: History and clinical examination. Fever. Timepoint: Clinical examination in The end of the first, second and fourth weeks After surgery. Method of measurement: History and clinical examination. Presence of a mass at the surgical site. Timepoint: Clinical examination in The end of the first, second and fourth weeks After surgery. Method of measurement: History and clinical examination. Zanjan University of Medical Sciences Approved 2020-06-23 Ethics Committee of Zanjan University of Medical Sciences Gavazang Road, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)