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IRCT20230510058145N1 IRCT 2023-06-06 Shahid Beheshti University of Medical Sciences Assessment of the Effect of Local Scrophularia Striata Solotion on Healing of Peristomal Wound Assessment of the Effect of Local Scrophularia Striata Solotion on Healing of Peristomal Wound in Patients Referring to Tehran Ostomi Assosiation 2023-05-22 anticipated 100 Complete https://irct.ir/trial/70047 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method takes place in two stages. In the first stage, the samples are entered into the study in the accessible(continuous) method. In the second stage, the samples will be randomly assigned to two control and test groups. Randomization will be done using Excel software and the rand command. 3 peristomal skin complications. Intervention 1: Intervention group: Patients in the intervention group are taught that after cleaning the skin around the stoma with water, apply the local solution of Local Scrophularia Striata provided to them at a specified time using an applicator on the skin around the stoma, and this Repeat the work every day for 14 consecutive days. During the intervention, the wound around the stoma is evaluated by the tool for examining the skin around the stoma on the 3rd and 21st days, the duration of the treatment is evaluated by visiting the patient in person, and on the 7th and 14th, the skin around the stoma is evaluated virtually by the photos sent by the patients of the skin around the stoma. An ostomy will be made. It should be noted that during the study, patients will be continuously taught through virtual communication channels such as WhatsApp. (The preparation of the solution is that theLocal Scrophularia Striata collected in dry shade and after the plant extract is powdered with hydroalcoholic solvent (70%) is prepared by the maceration method for 72 hours. Then, the solution is passed through a strainer and If necessary, the solvent will be removed, the obtained solution will be poured into sterile containers and will be provided to the patient for topical use. Intervention 2: Control group: Patients in the control group are taught to apply the chamomile ointment used in the ostomy center, which is provided to them, to the skin around the ostomy at a specified time after cleaning the skin around the ostomy with water. Repeat every day for 14 consecutive days. During the intervention, the wound around the stoma is evaluated by the tool for examining the skin around the stoma on the 3rd and 21st days, the duration of the treatment is evaluated by visiting the patient in person, and on the 7th and 14th, the skin around the stoma is evaluated virtually by the photos sent by the patients of the skin around the stoma. An ostomy will be made. It should be noted that during the study, patients will be continuously taught through virtual communication channels such as WhatsApp. Yes - There is a plan to make this available What will be shared: Results and data that are not ethically prohibited will be made available When: 6 months after printing the results To whom: Person responsible for scientific inquiries & Person responsible for general inquiries Conditions: Checking for non-contradiction with the ethical principles of research and preserving the effect of ownership Where to obtain: Person responsible for scientific inquiries & Person responsible for general inquiries How to obtain: Checking for non-contradiction with the ethical principles of research and preserving the effect of ownership Comments:
public kimia Miri
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 kimiamiri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mitra Zandi
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 mitra.zandi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Not using drugs that affect the wound, such as corticosteroids, anti-inflammatory steroids Absence of infection symptoms such as fever, discharge No need for surgery and wound healing Not suffering from skin diseases such as lupus, psoriasis, dermatitis Insensitivity to the Scrophularia Striata plant No radiotherapy or chemotherapy in the last 4 months 18 years no limit Both The use of drugs effective on wounds such as corticosteroids, anti-inflammatory steroids Having symptoms of infection such as fever, discharge The need for surgery and wound healing Suffering from skin diseases such as lupus, psoriasis, dermatitis Allergy to the Scrophularia Striata plant History of radiotherapy or chemotherapy in the last 4 months K91.4 Colostomy and enterostomy malfunction Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group are taught that after cleaning the skin around the stoma with water, apply the local solution of Local Scrophularia Striata provided to them at a specified time using an applicator on the skin around the stoma, and this Repeat the work every day for 14 consecutive days. During the intervention, the wound around the stoma is evaluated by the tool for examining the skin around the stoma on the 3rd and 21st days, the duration of the treatment is evaluated by visiting the patient in person, and on the 7th and 14th, the skin around the stoma is evaluated virtually by the photos sent by the patients of the skin around the stoma. An ostomy will be made. It should be noted that during the study, patients will be continuously taught through virtual communication channels such as WhatsApp. (The preparation of the solution is that theLocal Scrophularia Striata collected in dry shade and after the plant extract is powdered with hydroalcoholic solvent (70%) is prepared by the maceration method for 72 hours. Then, the solution is passed through a strainer and If necessary, the solvent will be removed, the obtained solution will be poured into sterile containers and will be provided to the patient for topical use. Control group: Patients in the control group are taught to apply the chamomile ointment used in the ostomy center, which is provided to them, to the skin around the ostomy at a specified time after cleaning the skin around the ostomy with water. Repeat every day for 14 consecutive days. During the intervention, the wound around the stoma is evaluated by the tool for examining the skin around the stoma on the 3rd and 21st days, the duration of the treatment is evaluated by visiting the patient in person, and on the 7th and 14th, the skin around the stoma is evaluated virtually by the photos sent by the patients of the skin around the stoma. An ostomy will be made. It should be noted that during the study, patients will be continuously taught through virtual communication channels such as WhatsApp. On Healing of Peristomal Wound Using the ostomy skin tool. Timepoint: The skin around the stoma will be examined on days 3, 7, 14 and 21 of treatment. Method of measurement: ostomy skin tool. Shahid Beheshti University of Medical Sciences Approved 2023-04-25 Ethics committee in research of School of pharmacy, nursing & midwifery , Shahid Beheshti Universi School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran Tehran Tehran Iran (Islamic Republic of)