The Effect of of Vancomycin powder and Povidon-Iodine in the Prevention of Wound infection in Open Lower-limb Fractures Undergoing Open Reduction and Internal Fixation

Prevention of wound infection in patients with open fractures undergoing internal fixation surgery

A clinical trial with two control and intervention groups, with parallel, three-blind, randomized, sample size 40, a random number table will be used for randomization

This study will be performed on patients with open type 1 and 2 gastillo-Anderson fractures The present study will be performed in Ali Ibn Abitaleb (AS) Hospital in Rafsanjan. Methods: In both control and intervention groups, first the initial preparation will be done using 7% betadine solution for 5 minutes. Then, for secondary skin preparation before surgery, in the intervention group, 2 grams of vancomycin powder in the amount of 2 grams is also used. In the control group, however, the skin in the second stage will be prepared using only 10% betadine. The study is of the 3-blind type. The patient, the researcher, and the analyzers are blinded.

Inclusion criteria initially include those with open fractures between the ages of 18 and 65. Also, their body mass index should be in the normal range and they should not have underlying and autoimmune diseases

In both control and intervention groups, initial preparation will be performed using 5% betadine solution for 5 minutes. Then, for secondary skin preparation before surgery, in the intervention group, 2 grams of vancomycin powder in the amount of 2 grams is used together with betadine. In the control group, however, the skin in the second stage will be prepared using only 10% betadine.

rate of infection; The rate of use of injectable and oral antibiotics

Randomization method: Simple randomization The method of assigning people to two groups of control and intervention will be so that the researcher uses a random table of numbers. This table contains a set of masses of numbers that are produced without a specific pattern or order and completely randomly and It is shown as a table. The researcher will consider two columns A (intervention) and B (control). After that the researcher touches one of the table numbers randomly and without looking at the table. If the even number is placed under the finger, the even sample will be considered for column A (intervention group) and if the odd number is placed, will be considered for column B (control group). Until it reaches the desired sample size in each group.

completely, the purpose of the study will be explained to patients, and if they are satisfied, those who have criteria for entering and answer positively to the research proposal will enter the study. All patients will be explained how to intervene, but patients will have no information about whether they will be allocated in the control or intervention group, and after sampling and analyzing the data, Information is given for both groups to performance of ethic of research (single blind). The intervention is performed by the researcher but randomization of people is done by the researcher, expert colleague to determine the control group or intervention and the researcher is unaware of the process until the end of the sampling stage. Before the researcher enters the operation field, the solution, will be provided by the research colleague. It should be noted that Poidon Aidan solution alone, have the same color and odor as well as the combination of betadine and vancomycin, , and experiments have confirmed this (double-blind). The statistical analyzer and the data safety and monitoring committee have no information about which data belongs to which control or intervention group, and only the checklist that filled by the researcher during the evaluation and analysis of the data is provided to them (triple-blind).

Published with the necessary coordination