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IRCT20220821055766N1 IRCT 2022-08-31 Hamedan University of Medical Sciences Comparative study of appendectomy wound healing by semi-plastic and subcuticular methods. Comparative study of appendectomy wound healing by semi-plastic and subcuticular methods. 2022-09-23 anticipated 80 Complete https://irct.ir/trial/65409 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: We will use the quadruple block randomization method. For this purpose, we prepare four sheets of paper. On two sheets we write the letter S meaning "semi-plastic" and on the other two sheets we write the letter C meaning "subcuticular". The sheets are mixed together and with the reference of each eligible patient, one of the sheets will be drawn randomly and based on this drawn sheet, whether it is S or C, they will be assigned to one of the two intervention groups. After all four sheets are randomly drawn, the above procedure will be continued for the next four patients until the desired sample size (80 patients) is reached, Blinding description: In this study, the participants and patients are aware of the general process of the research, but they are unaware of the division into intervention groups in randomization. Also, the person responsible for data collection and the person responsible for data analysis are also unaware. N/A Appendicitis. Intervention 1: The first intervention group: closing the wound with a semi-plastic suture. The method of conducting the study will be that after randomization, the patients, if placed in this group, will undergo surgery by a surgeon and scrub with a similar method. After appendectomy and after ensuring hemostasis, the layers of peritoneum, muscles and fascia will be sewn separately and then according to the placement of patients in this intervention group, they will be sutured in the relevant skin area, which will be sutured using Nylon thread (Kat, No. 3-0, Supa Co., Iran) will be used by the surgeon in a semi-plastic way. Intervention 2: The second intervention group: closing the wound with subcuticular suture. The method of conducting the study will be that after randomization, if the patients are placed in this group, they will undergo surgery by a surgeon and scrub with a similar method. After appendectomy and after ensuring hemostasis, the layers of the peritoneum, muscles and fascia will be sewn separately, and then according to the placement of the patients in this intervention group, they will be sutured in the relevant skin area, which will be sutured using nylon thread. (Cut, No. 3-0, Supa Company, Iran) will be performed subcuticular by the surgeon. Yes - There is a plan to make this available What will be shared: All individual data is shared after de-identifying individuals, including: data on pain and wound healing. When: The data will be shared three months after the results are published. To whom: All researchers can take action to receive data. Conditions: The data is provided on the condition that, firstly, it has a clear purpose for using the data; secondly, if this data is used; The primary source of data should be mentioned. Where to obtain: To receive data, you can refer to the following email address: sara.banoei@gmail.com How to obtain: After sending the request to the email address, the data will be sent as soon as possible. Comments:
public Sara banoeizadeh
Hamadan University of Medical Sciences, Shahid Fahmideh St.
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 1037 sara.banoei@gmail.com Hamedan University of Medical Sciences scientific Dr. Behzad Imani
Hamadan University of Medical Sciences, Shahid Fahmideh St.
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 1037 behzadiman@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Appendicitis is uncomplicated The age range is 15-65 years old Willingness to attend the study 15 years 65 years Both Patients with subcutaneous fat greater than 4 cm Patients with underlying diseases Patients for whom a drain is placed at the surgical site according to the surgeon's order Patients who have received any type of antibiotic in the last 48 hours Patients who have a history of abdominal surgery Patients with acquired or congenital immunodeficiency Patients who smoke Patients taking immunosuppressive drugs Patients who, for any reason, cannot come for follow-up K38.8 Other specified diseases of appendix Prevention Prevention The first intervention group: closing the wound with a semi-plastic suture. The method of conducting the study will be that after randomization, the patients, if placed in this group, will undergo surgery by a surgeon and scrub with a similar method. After appendectomy and after ensuring hemostasis, the layers of peritoneum, muscles and fascia will be sewn separately and then according to the placement of patients in this intervention group, they will be sutured in the relevant skin area, which will be sutured using Nylon thread (Kat, No. 3-0, Supa Co., Iran) will be used by the surgeon in a semi-plastic way. The second intervention group: closing the wound with subcuticular suture. The method of conducting the study will be that after randomization, if the patients are placed in this group, they will undergo surgery by a surgeon and scrub with a similar method. After appendectomy and after ensuring hemostasis, the layers of the peritoneum, muscles and fascia will be sewn separately, and then according to the placement of the patients in this intervention group, they will be sutured in the relevant skin area, which will be sutured using nylon thread. (Cut, No. 3-0, Supa Company, Iran) will be performed subcuticular by the surgeon. The amount of wound secretions in two Semi-plastic Subcuticular suture methods will be compared. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. The color of wound secretions will be compared in two Semi-plastic Subcuticular suture methods. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. Wound odor in two Semi-plastic Subcuticular suture methods will be compared. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. The color of the tissues around the wound will be compared in two methods of Semi-plastic and Subcuticular suture. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. The condition of the wound in terms of granulation and epithelization will be compared in two methods of Semi-plastic and Subcuticular suture. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. The amount of pain in two Semi-plastic Subcuticular suture methods will be compared. Timepoint: Second day 36 hours after surgery, tenth day, one month after surgery. Method of measurement: Visual pain scale and VAS. The condition of the wound in terms of opening will be compared in two methods of Semi-plastic and Subcuticular suture. Timepoint: Second day, tenth, one month after surgery. Method of measurement: Wound healing checklist. The condition of the wound in terms of heat will be compared in two methods of Semi-plastic and Subcuticular sutures. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. The condition of the wound in terms of scar width will be compared in two methods of Semi-plastic and Subcuticular suture. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Wound healing checklist. Body imaging. Timepoint: Second day, tenth day, one month after surgery. Method of measurement: Littleton et al.'s Body Image Fear Questionnaire (BICI). Hamedan University of Medical Sciences Approved 2022-08-22 Ethics Committee of Hamadan University of Medical Sciences Hamedan University of Medical Sciences, Shahid Fahmideh St. Hamadan Hamadan Iran (Islamic Republic of)