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IRCT20220223054104N1 IRCT 2022-05-09 Shahid Beheshti University of Medical Sciences cesarean section site infection Evaluation of the effect of combined antibiotic regimen of cefazolin and azithromycin in comparison with cefazolin antibiotic regimen on the incidence of non-emergency cesarean section infection 2022-05-21 anticipated 204 Complete https://irct.ir/trial/62941 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple individual randomization, with Random Number Generation computer software A random number is a number chosen from a pool of limited or unlimited numbers that has no discernible pattern for prediction. The pool of numbers is almost always independent from each other. However, the pool of numbers may follow a specific distribution. For example, the height of the students in a school tends to follow a normal distribution around the median height. If the height of a student is picked at random, the picked number has a higher chance to be closer to the median height than being classified as very tall or very short. The random number generators above assume that the numbers generated are independent of each other, and will be evenly spread across the whole range of possible values. A random number generator, like the ones above, is a device that can generate one or many random numbers within a defined scope. Random number generators can be hardware based or pseudo-random number generators. Hardware based random-number generators can involve the use of a dice, a coin for flipping, or many other devices, Blinding description: The study is two-blind and patients, surgeons and researchers themselves will not know which group the patient is in. After randomization using the software, neither the patient nor the researcher knew which group the patient was in, and whether or not they were to receive azithromycin preoperatively. 2-3 Surgical site infection. Intervention 1: Intervention group: All patients will have a bath with antibacterial soap the night before the operation, and the hair on the area before the operation and before the operation will be cut with scissors for all patients, and the vital signs of the patients will be recorded before the operation. In the experimental group, in addition to intravenous cefazolin, based on the appearance of body mass before pregnancy or early pregnancy (for the appearance of body mass less than 30, two grams of cefazolin and for the appearance of body mass more than 30, three grams of cefazolin) as a bolus infusion 30 to 60 Minutes before skin incision, 500 mg intravenous azithromycin will be given as a continuous infusion for 30 to 60 minutes. It should be noted that the dose of azithromycin is the same in all patients with different body mass profile and only the dose of cefazolin will be adjusted based on body mass profile. In addition, in patients with a body mass index of more than 30, if the duration of the operation is more than one and a half hours, the patient's intravenous dose of cefazolin will be repeated. It is not an action. In patients with a body mass index of less than 30, the dose of the antibiotic cefazolin will be repeated if the duration of the operation is more than 3 hours. In the operating room, the third degree of obstetrics and gynecology assistants is performed with the same technique, and in all operations, hand washing is performed with the same technique and chlorhexidine solution by scrub, circular and surgeon. Also, for all patients with peripheral abdominal skin, iodine solution is infused at the surgical site. Skin incisions are made in all patients with a scalpel and no catheter is used during the operation for any of the patients. Also, after the placenta is removed, the placenta is removed by applying a gentle stretch to the umbilical cord and the uterus will be swiped with two sterile gases. The peritoneum will be repaired with zero vicryl yarn and the fascia will be repaired with zero nylon as a continuum. And the tissue under the skin, if it is more than two centimeters thick, is approached with three zeros with vicryl thread, and the skin is repaired with two zeros with nylon thread as a continuum, and finally the incision is bandaged. It should be noted that the duration of the operation, the type of patient incision and vital signs will be recorded by the researcher in the questionnaire. After the operation, patients are transferred to the post-part ward and those who need ICU hospitalization are excluded from the study. In all patients in the first 24 hours of surgery based on body mass profile, intravenous cefazolin ampules will be administered every 6 hours up to 3 doses. For all patients, the dressing will be removed after 24 hours and patients will be treated within 48 hours after surgery. Surgery site infections include fever and chills, erythema, warmth, tenderness, swelling, purulent discharge from the incision site, uterine tenderness, and purulent vaginal discharge. In case of symptoms of infection, a complete evaluation is done until treatment. Patients are discharged without symptoms and are followed up by a researcher at the clinic 10 days after surgery. At the time of referral, fever, chills, erythema, warmth, tenderness, swelling, purulent discharge from the incision, uterine tenderness, and purulent vaginal discharge are evaluated. If there is evidence of infection, follow-up is done until complete treatment. Otherwise, 30 days after the operation, they will be followed up again by referring to the clinic for signs of infection, and then the rate of infection will be determined in both groups. The two groups will be compared. Intervention 2: Control group: All patients will have a bath with antibacterial soap the night before the operation, and the hair on the area before the operation and before the operation will be cut with scissors for all patients, and the vital signs of the patients will be recorded before the operation. In the control group, intravenous cefazolin based on the appearance of body mass before pregnancy or early pregnancy (for the appearance of body mass less than 30, two grams of cefazolin and for the appearance of body mass more than 30, three grams of cefazolin) as a bolus infusion 30 to 60 minutes before It will be prescribed from the skin incision. Yes - There is a plan to make this available What will be shared: Information about the consequences considered in the study can be shared. When: Starting 6 months after publication To whom: All researchers in academia and industry can access the information in this trial. Conditions: The data of this study can be used for meta-analysis in future studies. Where to obtain: Applicants must send an email in English to the email address of Mahsa Eskandari, the project manager. mahsaeskandariuni@gmail.com How to obtain: An email in English containing the required information will be sent to the lead developer and the reason for the need and the location of the information will be reported to them. Within 10 working days of sending the email, the review request and information will be provided in the form of an email. Comments:
public Mahsa Eskandari
No. 46, Nastaran alley, Simonbolivar Ave, North Janatabad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 4483 4648 mahsaeskandariuni@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahsa Eskandari
No. 46, Nastaran alley, Simonbolivar Ave, North Janatabad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 4483 4648 mahsaeskandariuni@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All women candidate for elective cesarean section in Mahdie hospital no limit no limit Female Patients who do not consent to participate in the study. T81.4XXA Infection following a procedure, subsequent encounter Prevention Prevention Intervention group: All patients will have a bath with antibacterial soap the night before the operation, and the hair on the area before the operation and before the operation will be cut with scissors for all patients, and the vital signs of the patients will be recorded before the operation. In the experimental group, in addition to intravenous cefazolin, based on the appearance of body mass before pregnancy or early pregnancy (for the appearance of body mass less than 30, two grams of cefazolin and for the appearance of body mass more than 30, three grams of cefazolin) as a bolus infusion 30 to 60 Minutes before skin incision, 500 mg intravenous azithromycin will be given as a continuous infusion for 30 to 60 minutes. It should be noted that the dose of azithromycin is the same in all patients with different body mass profile and only the dose of cefazolin will be adjusted based on body mass profile. In addition, in patients with a body mass index of more than 30, if the duration of the operation is more than one and a half hours, the patient's intravenous dose of cefazolin will be repeated. It is not an action. In patients with a body mass index of less than 30, the dose of the antibiotic cefazolin will be repeated if the duration of the operation is more than 3 hours. In the operating room, the third degree of obstetrics and gynecology assistants is performed with the same technique, and in all operations, hand washing is performed with the same technique and chlorhexidine solution by scrub, circular and surgeon. Also, for all patients with peripheral abdominal skin, iodine solution is infused at the surgical site. Skin incisions are made in all patients with a scalpel and no catheter is used during the operation for any of the patients. Also, after the placenta is removed, the placenta is removed by applying a gentle stretch to the umbilical cord and the uterus will be swiped with two sterile gases. The peritoneum will be repaired with zero vicryl yarn and the fascia will be repaired with zero nylon as a continuum. And the tissue under the skin, if it is more than two centimeters thick, is approached with three zeros with vicryl thread, and the skin is repaired with two zeros with nylon thread as a continuum, and finally the incision is bandaged. It should be noted that the duration of the operation, the type of patient incision and vital signs will be recorded by the researcher in the questionnaire. After the operation, patients are transferred to the post-part ward and those who need ICU hospitalization are excluded from the study. In all patients in the first 24 hours of surgery based on body mass profile, intravenous cefazolin ampules will be administered every 6 hours up to 3 doses. For all patients, the dressing will be removed after 24 hours and patients will be treated within 48 hours after surgery. Surgery site infections include fever and chills, erythema, warmth, tenderness, swelling, purulent discharge from the incision site, uterine tenderness, and purulent vaginal discharge. In case of symptoms of infection, a complete evaluation is done until treatment. Patients are discharged without symptoms and are followed up by a researcher at the clinic 10 days after surgery. At the time of referral, fever, chills, erythema, warmth, tenderness, swelling, purulent discharge from the incision, uterine tenderness, and purulent vaginal discharge are evaluated. If there is evidence of infection, follow-up is done until complete treatment. Otherwise, 30 days after the operation, they will be followed up again by referring to the clinic for signs of infection, and then the rate of infection will be determined in both groups. The two groups will be compared. Control group: All patients will have a bath with antibacterial soap the night before the operation, and the hair on the area before the operation and before the operation will be cut with scissors for all patients, and the vital signs of the patients will be recorded before the operation. In the control group, intravenous cefazolin based on the appearance of body mass before pregnancy or early pregnancy (for the appearance of body mass less than 30, two grams of cefazolin and for the appearance of body mass more than 30, three grams of cefazolin) as a bolus infusion 30 to 60 minutes before It will be prescribed from the skin incision. Incidence and prevalence of cesarean section site infection. Timepoint: From the time of cesarean section until 30 days later. Method of measurement: Clinical evidence and signs of surgery site infection including fever and chills, erythema, warmth, tenderness, swelling, purulent discharge from the incision site, uterine tenderness and purulent vaginal discharge 24 and 48 hours after surgery and on days 10 and 30 after The action is evaluated by the researcher. Shahid Beheshti University of Medical Sciences Approved 2022-03-11 Ethics committee of Shahid beheshti University of Medical Sciences Shahid beheshti medical university, Koodakiar street, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)