]>
IRCT20230703058652N1 IRCT 2023-09-13 Ahvaz University of Medical Sciences intraarticular vancomycin in hip hemiarthroplasty The effects of intraarticular vancomycin in preventing infection in patients undergoing hip hemiarthroplasty 2023-06-21 anticipated 48 Complete https://irct.ir/trial/71079 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: from 48 patients that will meet the conditions for entering the study, they will be randomized using the block randomization method and blocks size of four and will be divided into two groups receiving vancomycin and the group not receiving vancomycin in surgery wound. According to the number of study patients, which is 48, the number of 12 blocks with size of 4 is determined for each block. After determining the number of blocks and the capacity of each block, randomization of patients within the block is done using pre-written cards. We consider group A as the group receiving vancomycin in the surgery wound, and group B as the group that does not receive vancomycin powder in the surgery wound. 2 cards named A and 2 cards named B are prepared , and we write the numbers 1 to 4 on the back of the cards, the number 1 is on the back of the A card, the number 2 is on the back of the B card, the number 3 is on the next A card, and the number 4 is on the next B card. Then, by using the engineering calculator and choosing the RAND option and choosing the interval 1-4, we get random numbers from 1-4 and according to the number obtained from the calculator, we take the card and look at the back of it to see that A or It is B and the first card is placed in the first house of the first block, the second card is placed in the second house of the first block, the third card is placed in the third house of the first block, and the fourth card is placed in the fourth house of the first block. We do this for all 12 blocks. And during the surgery of the patients, we start from the first house of the first block. If it is group A, vancomycin powder will be poured into the wound, and if it is group B, vancomycin powder will not be poured into the wound. And for the next patients, we will select their groups from the first to the twelfth block respectively. 3 Femoral neck fracture. Intervention 1: Intervention group: a group of patients who, after surgery, one gram of vancomycin powder will be poured into their surgical wound, and after that, the subcutaneous fascia and skin will be repaired. Intervention 2: Control group: a group of patients who will not receive vancomycin powder in the surgical site after surgery, but all surgical procedures are similar except for receiving vancomycin powder. Yes - There is a plan to make this available What will be shared: The data file will be shared in the format of spss software. It should be noted that only the information related to the main consequences will be possible to share. When: Data access will start 6 months after publication To whom: The data will be available to researchers working in academic institutions. Conditions: Data will only be available for use in review studies and meta-analyses. Where to obtain: Payam mohammadhosseini by academic email mohammadhoseini-p@ajums.ac.ir How to obtain: First, send an email to the author and mention the purpose of receiving the information. If there is no problem, you will receive the information one to three weeks later. Comments:
public Mohsen asgari
Azadegan Street, Imam Khomeini Hospital, Ahvaz, Iran.
Ahwaz Iran (Islamic Republic of) 6136683813 009884338301 mohsenasgari8@gmail.com Ahvaz University of Medical Sciences scientific Payam mohammadhosseini
Azadegan Street, Imam Khomeini Hospital, Ahvaz, Iran.
Ahvaz Iran (Islamic Republic of) 6155693118 +98 61 3292 1836 mohammadhoseini-p@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Femoral neck fracture patients candidates for primary hip hemiarthroplasty Age over 50 years Patient consent to participate in the study 50 years no limit Both patients that are candidate for total hip arthroplasty known allergy to vancomycin patients with renal disease and those have high creatinin level active infection, local or systemic patients with skin disorders in surgery site patients undergo revision surgery Auditory disorders immunocompromization S72.0 Fracture of head and neck of femur Prevention Prevention Intervention group: a group of patients who, after surgery, one gram of vancomycin powder will be poured into their surgical wound, and after that, the subcutaneous fascia and skin will be repaired. Control group: a group of patients who will not receive vancomycin powder in the surgical site after surgery, but all surgical procedures are similar except for receiving vancomycin powder. Deep infection of surgery site. Timepoint: 7 , 14 , 30 , 60 , 90 days after surgery. Method of measurement: Inspection and physical examination. Superficial infection of surgery site. Timepoint: 7 , 14 , 30 , 60 , 90 days after surgery. Method of measurement: Inspection and physical examination. Erythrocytecsedimentation rate. Timepoint: Before surgery and one month after surgery. Method of measurement: By blood test. C- reactive protein. Timepoint: Before surgery and one month after surgery. Method of measurement: By blood test. Ahvaz University of Medical Sciences Approved 2023-06-17 Ethics committee of Ahwaz jondishapour University of Medical Sciences Jundishapur University of Medical Sciences, Esfand Ave, Golestan Blvd., Ahvaz, Iran. Ahvaz Khouzestan Iran (Islamic Republic of)