The effects of intraarticular vancomycin in preventing infection in patients undergoing hip hemiarthroplasty

Investigating the effects of intraarticular vancomycin in preventing infection in patients undergoing hip hemiarthroplasty

The clinical trial has two groups including control and intervention in parallel groups. Randomization will be done in permutation blocks of four, which will be done on 48 patients.

The place of study is Golestan and Imam Khomeini hospitals in Ahvaz. Surgeries will be performed in the general operating room of these two hospitals under the supervision of professors in a fixed setting, and the follow-up of patients after the operation will be done in the orthopedic clinic of these two hospitals.

Inclusion criteria: - Age over 50 years - Femoral neck fracture patients candidates for primary hip hemiarthroplasty - Patient consent to participate in the study Exclusion criteria: - Presence of active, local or systemic infections - Patients with a history of infection in the hip joint on the same side - Patients with skin disorders in surgery site - Patients undergoing revision surgery - Patients with known allergy to vancomycin - Renal disease and patients with high creatinine before surgery - Auditory problems

The intervention group receive intrawound vancomycin after hip hemiarthroplasty The control group does not receive intraoperative vancomycin.

Superficial infection and deep infection of the surgery site

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.

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.

Data access will start 6 months after publication

The data will be available to researchers working in academic institutions.

Data will only be available for use in review studies and meta-analyses.

Payam mohammadhosseini by academic email mohammadhoseini-p@ajums.ac.ir

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