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IRCT20240212060966N1 IRCT 2024-02-21 Iran University of Medical Sciences Comparison of the effect of surgical site skin preparation with povidone-iodine solution at two different temperatures on the antimicrobial effect and surgical wound infection Comparison of the effect of surgical site skin preparation with povidone-iodine antiseptic at two different temperatures on the microbial load and surgical site infection in laparotomy patients 2024-04-13 anticipated 126 Complete https://irct.ir/trial/75499 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: simple randomization Randomization tool: using a table of random numbers made by the computer, Blinding description: In this research, single blinding will be used; So that the samples will not be informed about the antiseptic temperature used for them. But the researcher and the surgical team will know the antiseptic temperature used for each sample. 3 Surgical site infection. Intervention 1: Intervention group: surgical site Skin preparation will be done in two stages. At first, before starting the skin preparation process, a culture will be taken from the skin of the surgical site with a sterile swab. In this way, an initial culture sample will be taken using a wet swab soaked in physiological serum and the swab will be rubbed on the blood agar culture medium. Then, in the initial stage of skin preparation, povidone-iodine 7.5% will be used at a temperature of 22 degrees Celsius. The skin preparation will be done in a circular manner from the center of the surgical incision to the periphery and this will be done with 3 separate sterile gauzes. After performing the initial stage of skin preparation,we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Before starting the secondary stage, a skin culture will be taken from the surgical site. The second culture sample will be taken using a sterile swab dipped in physiological serum. In this way, the swab will be rubbed on the blood agar medium. Then, in the secondary stage, povidone-iodine 10% will be used at a temperature of 35 degrees Celsius. Skin preparation will be done in a circular manner from the center of the surgical incision to the periphery by 3 separate gas sterilizers. After performing the secondary stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Again, a culture will be taken from the skin of the surgical site with a sterile swab dipped in physiological serum. In this way, the swab will be rubbed on the blood agar culture medium. Then, the surgical site will be covered with sterile cloths and sterile plastic covers, and the surgical process will continue. The culture samples will be sent to the laboratory to determine the microbial load. 24 hours after the surgery, the dressing of the surgical site will be changed for the first time by the researcher and the relevant doctor. The surgical site will be observed and examined for signs of surgical site infection. The symptoms will be recorded in the researcher's form for recording surgical site infection symptoms. The patient will be trained. The form for recording the symptoms of surgical site infection will be provided to the patient so that he or she can check the surgical site within one month after the surgery and record the symptoms in the said form. Then at the end of 30 days of the said form will be collected by the researcher. Finally, two groups will be compared. Intervention 2: Control group: Surgical site skin preparation will be done in two stages. First, before starting the skin preparation process, a sterile swab will be taken from the skin of the surgical site. In this way, a primary culture sample will be taken using a wet swab dipped in physiological serum and rubbed on the blood agar culture medium. Then, in the initial stage of skin preparation, povidone iodine 7.5% will be used at a temperature of 22 degrees Celsius. Skin preparation will be done in a circular manner from the center of the surgical incision to the periphery, and this will be done with 3 separate sterile gauzes. After performing the initial stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Before starting the secondary stage, the second culture will be taken from the skin of the surgical site. Then, in the secondary stage, povidone-iodine 10% at 22°C will be used. The preparation of the skin will be done in a circular manner from the center of the surgical incision to the periphery by 3 separate gas sterilizers. After performing the secondary stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Again, a culture will be taken from the skin of the surgical site with a sterile swab dipped in physiological serum. Then, the surgical site will be covered with sterile cloths and sterile plastic covers, and the surgical process will continue. Culture samples will be sent to the laboratory to determine the microbial load. 24 hours after the surgery, the dressing of the surgical site will be changed for the first time by the researcher and the relevant doctor. The surgical site will be observed and examined for signs of surgical site infection. The symptoms will be recorded in the researcher's form for recording surgical site infection symptoms. The patient will be trained. The form for recording the symptoms of surgical site infection will be provided to the patient so that he or she can check the surgical site within one month after the surgery and record the symptoms in the said form. Then at the end of 30 days of the said form will be collected by the researcher. Finally, two groups will be compared. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fardin Amiri
Faculty of Paramedicine,Iran University of Medical Sciences, between the intersection of Sheikh Fazlullah Nouri and Shahid Chamran, Shahid Hammat highway, next to milad tower, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4600 amiri.fa@iums.ac.ir Iran University of Medical Sciences scientific Fardin Amiri
Faculty of Paramedicine,Iran University of Medical Sciences, between the intersection of Sheikh Fazlullah Nouri and Shahid Chamran, Shahid Hammat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4600 amiri.fa@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 to 55 years Having at least a diploma degree No diabetes No history of laparotomy surgery Body mass index less than 35 Absence of immune system deficiency and no use of immunosuppressive drugs Absence of local infection near the surgical site or systemic infection Not being allergic to povidone-iodine antiseptic No history of malignancy and radiation therapy Absence of severe skin rash at the surgical site Not using broad-spectrum antibiotics within a month before going to the hospital having Elective surgery 18 years 55 years Both Emergency laparotomy surgery Disruption in the surgical process that leads to the contamination of the instruments or the surgical field immune system deficiency and using immunosuppressive drugs having diabetes allergic to povidone-iodine antiseptic The presence of rashes and severe skin diseases at the surgical site using broad-spectrum antibiotics within a month before going to the hospital morbid obesity Prevention Prevention Intervention group: surgical site Skin preparation will be done in two stages. At first, before starting the skin preparation process, a culture will be taken from the skin of the surgical site with a sterile swab. In this way, an initial culture sample will be taken using a wet swab soaked in physiological serum and the swab will be rubbed on the blood agar culture medium. Then, in the initial stage of skin preparation, povidone-iodine 7.5% will be used at a temperature of 22 degrees Celsius. The skin preparation will be done in a circular manner from the center of the surgical incision to the periphery and this will be done with 3 separate sterile gauzes. After performing the initial stage of skin preparation,we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Before starting the secondary stage, a skin culture will be taken from the surgical site. The second culture sample will be taken using a sterile swab dipped in physiological serum. In this way, the swab will be rubbed on the blood agar medium. Then, in the secondary stage, povidone-iodine 10% will be used at a temperature of 35 degrees Celsius. Skin preparation will be done in a circular manner from the center of the surgical incision to the periphery by 3 separate gas sterilizers. After performing the secondary stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Again, a culture will be taken from the skin of the surgical site with a sterile swab dipped in physiological serum. In this way, the swab will be rubbed on the blood agar culture medium. Then, the surgical site will be covered with sterile cloths and sterile plastic covers, and the surgical process will continue. The culture samples will be sent to the laboratory to determine the microbial load. 24 hours after the surgery, the dressing of the surgical site will be changed for the first time by the researcher and the relevant doctor. The surgical site will be observed and examined for signs of surgical site infection. The symptoms will be recorded in the researcher's form for recording surgical site infection symptoms. The patient will be trained. The form for recording the symptoms of surgical site infection will be provided to the patient so that he or she can check the surgical site within one month after the surgery and record the symptoms in the said form. Then at the end of 30 days of the said form will be collected by the researcher. Finally, two groups will be compared. Control group: Surgical site skin preparation will be done in two stages. First, before starting the skin preparation process, a sterile swab will be taken from the skin of the surgical site. In this way, a primary culture sample will be taken using a wet swab dipped in physiological serum and rubbed on the blood agar culture medium. Then, in the initial stage of skin preparation, povidone iodine 7.5% will be used at a temperature of 22 degrees Celsius. Skin preparation will be done in a circular manner from the center of the surgical incision to the periphery, and this will be done with 3 separate sterile gauzes. After performing the initial stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Before starting the secondary stage, the second culture will be taken from the skin of the surgical site. Then, in the secondary stage, povidone-iodine 10% at 22°C will be used. The preparation of the skin will be done in a circular manner from the center of the surgical incision to the periphery by 3 separate gas sterilizers. After performing the secondary stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Again, a culture will be taken from the skin of the surgical site with a sterile swab dipped in physiological serum. Then, the surgical site will be covered with sterile cloths and sterile plastic covers, and the surgical process will continue. Culture samples will be sent to the laboratory to determine the microbial load. 24 hours after the surgery, the dressing of the surgical site will be changed for the first time by the researcher and the relevant doctor. The surgical site will be observed and examined for signs of surgical site infection. The symptoms will be recorded in the researcher's form for recording surgical site infection symptoms. The patient will be trained. The form for recording the symptoms of surgical site infection will be provided to the patient so that he or she can check the surgical site within one month after the surgery and record the symptoms in the said form. Then at the end of 30 days of the said form will be collected by the researcher. Finally, two groups will be compared. Microbial load. Timepoint: microbial cultures will be taken in three stages before the surgical site skin preparation, after the initial stage of disinfection of the surgical site and after the secondary stage of disinfection of the surgical site with povidone-iodine 10%. Method of measurement: taking microbial culture and counting microbial colonies 24 hours after incubation. Surgical site infection. Timepoint: Observation and examination of the surgical wound after 24 hours and 30 days after surgery. Method of measurement: Observing and examining the surgical wound and entering the symptoms in the surgical site infection checklist. Iran University of Medical Sciences Approved 2024-02-05 Ethics committee of iran University of Medical Sciences Faculty of allied medicine, Iran univarsity of medical sciences ,Hemmat highway, next to the milad tower, tehran, iran Tehran Tehran Iran (Islamic Republic of)