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IRCT20221004056086N1 IRCT 2022-10-19 Esfahan University of Medical Sciences Effect of aftingel ointment in healing of mouth ulcers Comparison of the Effectiveness of local aftingel ointment and First generation oral cephalosporins in Improving lip mucosal traumatic ulcers(laceration) in patients older than 17 years old 2022-10-23 anticipated 100 Complete https://irct.ir/trial/66184 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients with ulcers in the mouth area are collected and then randomly assigned to control and intervention groups, and during the sample selection, the patients in each group are matched in terms of sex, cause of ulcer, severity of infection, Age, physical condition and type of nutrition, Blinding description: In this study, 100 patients with ulcers in the mouth area are collected and then randomly assigned to control and intervention groups (50 people in each group) and a satisfaction form was prepared for each of the experimental units, and complete explanations about how to conduct the study and its interventions are presented to the patients so that the ethical context of the project is respected. Both groups were asked about wound changes (appearance, size and duration of complete healing of wound), pain (based on VAS) and patient's satisfaction (based on Likert scale) and records in the forms prepared for this purpose by a constant questioner, who is not a researcher, and unaware of group's type. 2 Traumatic wounds of the oral mucosa (laceration). Intervention 1: Control group: preparation of the patient and the doctor, local anesthesia and preferably nerve block of the involved area, cleansing by washing with normal saline and wound repair with the simple suture (if needed) with absorbable thread, mainly vicryl 0-4 or 0-5 with 4 knots at least (depending on wound depth, number of suture layers varies from one to three), rewash with normal saline serum, common oral antibiotic treatment (first generation cephalosporins) for 3 to 7 days Tetanus immunoprophylaxis (according to the standard protocol) is performed routinely in the emergency room and gargling warm salt water solution three times a day at home. Intervention 2: Intervention group: All procedures are similar to the control group, but instead of systemic antibiotic treatment, the patient is treated locally with Aftingel. Open the nozzle and slowly put a drop of Aftin gel on an Qtip and then press it gently for 20 seconds exactly on the wound area and repeat these steps 5 times a day. This is repeated and continued for two weeks, and other wound care items are similar to control group. 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: It will be available for researchers working in academic and scientific institutions and those working in industry. Conditions: Data analysis is allowed for use in other scientific studies. The submitted request will be reviewed by principal and scientific officer of this project, and if both agree, the results will be provided to the applicant. Where to obtain: pnasr0895@gmail.com(Parisa Nasr Isfahani) azizkhani1980@gmail.com(Reza Azizkhani) How to obtain: After demanders send request's e-mail and explain complete informations about type of required informations and reasons of request and how to use them, will be reviewed their request within a maximum of 3 working days, the documents will be provided to them through the possible channels. Comments:
public Reza Azizkhani
Department of Emergency Medicine, Alzahra hospital, Soffe Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 azizkhani1980@gmail.com Esfahan University of Medical Sciences scientific Parisa Nasr Isfahani
No. 59, masoud alley, khaiam Ave
Isfahan Iran (Islamic Republic of) 8184653417 +98 31 3233 4724 pnasr0895@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient satisfaction to participate in the study Age older than 17 years Absence of underlying disease such as liver and kidney disease, Diabetes Mellitus, progressive neurologic disorders, GI disorders and coagulopathy and Wound healing disorders Not taking any antibiotics for any reason less than 24 hours from the onset of the ulcer Wounds without requirement to debridement and smaller than 5 cm without malnutrition Simple wound without nerve damage and fracture Not taking medicine with known interference in wound healing 17 years no limit Both Incomplete information about type of wound Patients who don't want to participate in this study at any time during the study Taking any antibiotics for any reason less than 24 hours from the onset of the ulcer Wounds that have been created for more than 12 hours Wounds larger than 5 cm Treatment - Drugs Treatment - Drugs Control group: preparation of the patient and the doctor, local anesthesia and preferably nerve block of the involved area, cleansing by washing with normal saline and wound repair with the simple suture (if needed) with absorbable thread, mainly vicryl 0-4 or 0-5 with 4 knots at least (depending on wound depth, number of suture layers varies from one to three), rewash with normal saline serum, common oral antibiotic treatment (first generation cephalosporins) for 3 to 7 days Tetanus immunoprophylaxis (according to the standard protocol) is performed routinely in the emergency room and gargling warm salt water solution three times a day at home. Intervention group: All procedures are similar to the control group, but instead of systemic antibiotic treatment, the patient is treated locally with Aftingel. Open the nozzle and slowly put a drop of Aftin gel on an Qtip and then press it gently for 20 seconds exactly on the wound area and repeat these steps 5 times a day. This is repeated and continued for two weeks, and other wound care items are similar to control group Wound length. Timepoint: On 0, 3 and 7th days of treatment. Method of measurement: graded ruler in centimeters. Wound healing time. Timepoint: On 0, 3 and 7th days of treatment. Method of measurement: Based on the length of wound in centimeters until complete wound healing. Patient satisfaction. Timepoint: On 0, 3 and 7th days of treatment. Method of measurement: Likert scale. Pain. Timepoint: On 0, 3 and 7th days of treatment. Method of measurement: Visual analouge scale(VAS). Esfahan University of Medical Sciences Approved 2022-10-11 Ethics committee of Isfahan University of Medical Sciences No.4, Isfahan university of medical science, Hezar jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)