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IRCT20230928059543N1 IRCT 2024-01-12 Shiraz University of Medical Sciences Comparison of two wound closure methods after knee joint replacement in diabetic patients Comparison of Surgical wound dehiscence and Infection rate in two Methods of Skin stapler and Nylon suture in Wound closure of Diabetic patients undergoing Total knee arthroplasty (TKA) 2024-03-01 anticipated 120 Complete https://irct.ir/trial/74754 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be randomly assigned to two groups of closure with nylon suture and closure with staples using Random Allocation computer Software (RAS)version 4.9 (Internet address: https://random-allocation-software.software.informer.com/2.0/ ). Random allocation by the permutation block method is listed in 15 blocks of 8 with random allocation software, the list provided is attached to the proposal. N/A Diabetes. Intervention 1: Control group: The first intervention group includes people who use nylon thread to close their wounds after knee replacement surgery. In the first group, surgical wound closure using 2-0 nylon thread (Supalon), monofilament with polyamide-6, which is produced by Supa company in Iran, will be done in a simple interrupted manner. Skin closure will be done at a 45-degree knee bend angle. Intervention 2: Intervention group: This group includes people whose wounds will be closed with skin staples after knee joint replacement surgery. In this group, surgical wound closure will be performed using a special covidin skin surgical stapler (Appose ULC 35W). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Study data will be available only to researchers working in academic and scientific institutions Conditions: By sending an email to the author responsible for the article, the data will be made available to experts in this field. Where to obtain: People can get the study data by sending an email to Armin Feridouni (author responsible for the article). Email: arminfereidoni@yahoo.com How to obtain: Ten days after receiving the email by the responsible author, the data will be available to the requesting person. Comments:
public Armin Fereidouni
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
Shiraz Iran (Islamic Republic of) 7167755954 +98 71 3753 2383 arminfereidoni@yahoo.com Shiraz University of Medical Sciences scientific Armin Fereidouni
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
Shiraz Iran (Islamic Republic of) 7167755954 +98 71 3753 2383 arminfereidoni@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Definitive diagnosis of diabetes through the examination of the patient's tests by an internal medicine specialist and the use of diabetes medications presence of fasting blood sugar between 70 and 130 mg/dL Age range from 40 to 90 years 40 years 90 years Both History of cancer and chemotherapy, uncontrolled internal and vascular diseases Reduction of blood albumin Taking systemic corticosteroid drugs before surgery Having a history of knee surgery or the presence of scars and wounds in the knee area Getting infectious and viral diseases (colds and COVID-19) before and after surgery Increased blood urea Suffering from immunosuppressive diseases E08 Diabetes mellitus due to underlying condition Treatment - Surgery Treatment - Surgery Control group: The first intervention group includes people who use nylon thread to close their wounds after knee replacement surgery. In the first group, surgical wound closure using 2-0 nylon thread (Supalon), monofilament with polyamide-6, which is produced by Supa company in Iran, will be done in a simple interrupted manner. Skin closure will be done at a 45-degree knee bend angle. Intervention group: This group includes people whose wounds will be closed with skin staples after knee joint replacement surgery. In this group, surgical wound closure will be performed using a special covidin skin surgical stapler (Appose ULC 35W). Wound infection. Timepoint: The evaluation of the results of the patient's wound in terms of the rate of wound infection will be followed up and recorded 2 to 8 weeks after the operation. Method of measurement: Surgical wound infection checklist. Wound dehiscence. Timepoint: The evaluation of the results of the patient's wound in terms of the rate of wound dehiscence will be followed up and recorded 2 to 8 weeks after the operation. Method of measurement: Surgical wound dehiscence checklist. Shiraz University of Medical Sciences Approved 2023-11-11 Ethics Committee of Shiraz University of Medical Sciences 5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz Shiraz Fars Iran (Islamic Republic of)