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IRCT20160301026861N3 IRCT 2023-04-24 Sanandaj University of Medical Sciences Comparison of the effect of two methods of primary washing of the area disinfected with brown betadine with 70% alcohol and normal saline on the incidence and severity of postoperative wound infection The Comparison of the Incidence and Severity of Wound Infection to 2 Methods of Primary Prep Washing with 70% Alcohol and Normal Saline in Patients Undergoing Orthopedic Surgery 2020-04-08 anticipated 190 Complete https://irct.ir/trial/69291 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of the study and based on the entry criteria, patients who meet the conditions for entry into the study are entered into the study. Then, considering the importance of random assignment in clinical trial studies to control possible confounders, the samples are randomly assigned to each of the intervention or control groups in the form of a double block, Blinding description: The method of blinding the study is three-blind. Patients undergoing orthopedic surgery as research samples will not know the type of intervention. Before the study, from an ethical point of view, the samples will be informed that one of two types of intervention may be done for them, and written consent will be obtained from them. The first researcher in the intervention and control group performs the necessary interventions. The second researcher measures the incidence and severity of wound infection after surgery without knowing the type of intervention and the groups; Therefore, as a second person, he will be blind to the study. Also, the statistical consultant as a data analyst will be unaware of the groups; therefore, he will be considered as the third person blinded to the study. N/A Primary prep area of patients candidates for elective orthopedic surgery of the upper limbs. Intervention 1: Intervention group: The surgical site must be completely shaved. The surgical area will be prepped with 5.7% betadine brown diluted with normal saline for three minutes. After the initial prep, betadine will be brown on the skin surface for two minutes. Then the surgical site is washed with 70% alcohol until the skin surface is free of betadine. Wait until the alcohol dries on the surface of the skin. After the intervention, secondary prep will be done with betadine 10% and with the help of three gauzes and for at least five minutes. Intervention 2: Control group: the surgical site must be completely shaved. The surgical area will be prepped with 7.5%brown betadine diluted with normal saline for three minutes. After the initial prep, brown will be on the skin surface for two minutes. Then, the surgical site is washed with normal saline until the skin surface is free of betadine. Then, using a sterile towel, the primary prep area will be dried. . After washing or normal saline serum and drying, secondary prep of the surgical area will be done again with betadine 10% and with the help of three gauzes and for at least five minutes. Yes - There is a plan to make this available What will be shared: Results of data analysis When: 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For use in meta-analysis, systematic review and compilation of clinical guidelines Where to obtain: Jamal Seidi Bs, MSc, PhD .Nursing Associate Professor of Nursing and Midwifery Faculty. Kurdistan University of medical sciences, Sanandaj, Iran Email : jamal.seidi@yahoo.com Jamal.seidi@muk.ac.ir mobile:+98-918-378-1006 How to obtain: Written and valid request by e-mail jamal.seidi@yahoo.com Comments:
public Jamal Seidi
Pasdaran Blvd; Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 0095 jamal.seidi@muk.ac.ir Sanandaj University of Medical Sciences scientific Jamal Seidi
Pasdaran Blvd; Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 0095 jamal.seidi@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) The patient is a volunteer for elective orthopedic surgery of the upper limb The patient is a volunteer to participate in the research The hair in the surgical area must be shaved before the operation The body mass index of the patient is less than 30 no limit no limit Both There should be no skin damage in the surgical area due to trauma The patient does not have any underlying diseases or skin allergies The patient does not have burns or previous surgery in the prep area The patient does not have vascular problems in the organ under surgery The patient does not have diseases related to the immune system and infectious diseases The patient does not have digestive or blood diseases Treatment - Surgery Treatment - Surgery Intervention group: The surgical site must be completely shaved. The surgical area will be prepped with 5.7% betadine brown diluted with normal saline for three minutes. After the initial prep, betadine will be brown on the skin surface for two minutes. Then the surgical site is washed with 70% alcohol until the skin surface is free of betadine. Wait until the alcohol dries on the surface of the skin. After the intervention, secondary prep will be done with betadine 10% and with the help of three gauzes and for at least five minutes. Control group: the surgical site must be completely shaved. The surgical area will be prepped with 7.5%brown betadine diluted with normal saline for three minutes. After the initial prep, brown will be on the skin surface for two minutes. Then, the surgical site is washed with normal saline until the skin surface is free of betadine. Then, using a sterile towel, the primary prep area will be dried. . After washing or normal saline serum and drying, secondary prep of the surgical area will be done again with betadine 10% and with the help of three gauzes and for at least five minutes. The incidence of wound infection after surgery with a score higher than ten from the wound evaluation and the absence of wound infection with a score lower than 10 will be measured by the ASEPSIS INDEX tool after orthopedic surgery. Timepoint: It will be measured once. The symptoms of wound infection will be monitored from the time after surgery until two weeks after discharge from the hospital, and on the 14th day after discharge, the scores obtained from the Asepsis index tool will be collected. Method of measurement: Based on the ASEPSIS INDEX tool, evaluation of wound healing after surgery including; Complementary antibiotic therapy (0-10 points), redness of the wound at the surgical site (0-5 points), serous discharge from the surgical site (0-5 points), deep disintegration of the wound (0-10 points), culture from the wound site and isolation of bacteria ( 0-10 points) Wound debridement under general anesthesia (0-10 points), drainage of purulent wound secretions under local anesthesia, purulent exudate (0-10 points), hospitalization for more than 14 days (0-5 points). The maximum score will be 70 and the minimum score will be zero. A score less than ten means complete healing of the wound and no wound infection. A score higher than ten means wound infection. The severity of wound infection after surgery will be determined based on the ASEPSIS INDEX standard tool. Based on this tool, a score of 0-10 indicates complete healing of the wound, a score of 11-20 indicates impaired wound healing, a score of 21-30 indicates partial wound infection, a score of 31-40 indicates moderate wound infection, and a score greater than 40 indicates severe wound infection. Timepoint: It will be measured once. The symptoms of wound infection will be monitored from the time after surgery until two weeks after discharge from the hospital, and on the 14th day after discharge, the scores obtained from the Asepsis index tool will be collected. Method of measurement: In this study, the average scores obtained from the ASEPSIS INDEX standard tool will be compared in two intervention and control groups. Sanandaj University of Medical Sciences Approved 2019-12-24 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Blvd; Faculty of Nursing and Midwifery; Kurdistan University of Medical Sciences, Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)