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IRCT20200128046289N1 IRCT 2020-02-22 Babol University of Medical Sciences comparison of efficacy of two treatment regimen,cefazolin alone with cefazolin plus metronidazol in the prevention of surgical site infections after hysterectomy comparison of efficacy of two treatment regimen,cefazolin alone with cefazolin plus metronidazol in the prevention of surgical site infections after hysterectomy 2020-02-04 anticipated 400 Complete https://irct.ir/trial/45459 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After obtaining informed consent from the patients, they were coded by random numbers that came out of the envelope and patients were divided into control and intervention groups. Then the treatment protocol is performed by the nurse and midwife for both groups. The treatment protocol in this study is as follows: Standard method: Two grams of intravenous cefazolin for the first group (as control group) one hour before surgery and two grams of intravenous cefazolin plus 500 mg metronidazole suppository one hour before surgery in the second group (intervention group), Blinding description: In this study, random numbers coded by the head-nurse and midwife are extracted from a pre-prepared envelope by the researcher. Then patients are divided into two groups: control and intervention. Research protocol of the study is performed by the head-nurse and midwife for both groups. The physician and patients are not aware of the chosen treatment protocol. 3 Skin Site Infection after Hysterectomy. Intervention 1: Patients who are candidate for hysterectomy receiving Cefazolin 2gr IV one hour before surgery alone as control group. Intervention 2: Patients who are candidate for hysterectomy receiving Cefazolin 2gr IV plus Metronidazole 500 mg IV one hour before surgery as intervention group. 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 No more information
public Masomeh Bayani
Ganjafrooz Ave,
BABOL Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ 009832238284 m_baiany@yahoo.com Babol University of Medical Sciences scientific Masomeh Bayani
Ganjafrooz Ave, Babol, Mazandaran, Iran
BABOL Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ 00981132199592-6 m_baiany@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) All women who are candidates for hysterectomy no limit no limit Female Sensitivities to cefazolin Sensitivities to metronidazole sensitivities to penicillins T81.4 Infection following a procedure Prevention Prevention Patients who are candidate for hysterectomy receiving Cefazolin 2gr IV one hour before surgery alone as control group. Patients who are candidate for hysterectomy receiving Cefazolin 2gr IV plus Metronidazole 500 mg IV one hour before surgery as intervention group. Postoperative infection. Timepoint: Twelve months. Method of measurement: Based on ICD-10 Code criteria description. Prevention of infection after hysterectomy. Timepoint: Thirty days after the hysterectomy. Method of measurement: Clinical signs of wound infection (redness, swelling, warmth, discharge). Babol University of Medical Sciences Approved 2019-01-20 Ethic committee of Babol University of Medical Sciences Ganjafrooz Ave, Babol, Mazandaran, Iran BABOL Mazandaran Iran (Islamic Republic of)