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IRCT20201119049441N1 IRCT 2021-01-18 Tehran University of Medical Sciences Effect of Dorema Ammoniacum Cream on the prevention of peripheral intravenous catheter-related phlebitis In patients admitted to surgery departments Effect of Dorema Ammoniacum Cream on the prevention of peripheral intravenous catheter-related phlebitis In patients admitted to surgery departments 2021-02-03 anticipated 110 Complete https://irct.ir/trial/52456 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After adapting the patient's condition to the inclusion criteria, patients are randomly assigned to one of the two experimental or control groups. Thus, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, on 6 cards as follows: AABB, ABBA, ABAB, BAAB, BABA, BBAA, then we randomly select a digit from 1 to 6 (With the help of a table of random numbers or we ask patient number one to choose a card at random). For example, if the number 2 is selected, it means that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention group, and we will continue this operation until the sample size reaches the quorum, Blinding description: The blinding of the study is that the Dorema Ammoniacum cream and placebo made by the research team are both completely similar in terms of color, odor, consistency and cans used, and the cans are named A and B by the cream maker. The patient, the researcher and the assistant researcher and the statistical analyzer have no information about how to name the cans and the contents inside them, and finally, after analyzing the data, the manufacturer of the cream will be asked about the contents of the cans. 3 Phlebitis. Intervention 1: Intervention group: In the intervention group, Dorema Ammoniacum cream is used. To prepare Dorema Ammoniacum cream, 100 grams of Dorema Ammoniacum resin oleogum is weighed and ground. 1 liter of 70 degree alcohol is added to it. Clears after 48 hours. Add another liter of alcohol and strain it again after 48 hours. The filtered solution is concentrated by rotary rotation. The concentrated solution is placed in a vacuum oven to form a powder. 5 g of the powder with 20 cc of distilled water is placed in an ultrasonic bath for 15 minutes to obtain a uniform liquid. A uniform liquid is added to 100 g of the base cream and it is beaten evenly with an electric mixer to obtain a uniform cream. It is then packed in 50 g containers. 70% alcohol is used only for extraction and after drying the extract, nothing of alcohol remains in the extract. Before using the cream, a skin allergy test is performed, in which some cream is rubbed on the patient's arm and after For 20 minutes the position is examined for redness, rash and other allergic reactions, and if there is no reaction, the drug will be tested on the patient. The product is standardized by spectrophotometric method based on the amount of spirochete compounds of terpenoic chromium acid 2-4-dione. Ash essential oil is also isolated and its compounds are identified by GC-MS. According to the European Pharmacopoeia, skin-mucosal products do not need to be sterilized. Intervention 2: Control group: The base cream is prepared by Farabi company and consists of Vaseline, glycerin, monostearate, beeswax, lanolin, stearic acid, alcohol, distilled water, triethanolamine. To prepare the placebo, the base cream is in 50 containers. It is warmly packaged. Before using the cream, a skin allergy test is performed, in which some cream is rubbed on the patient's arm, and after 20 minutes, the position for redness, rash and other allergic reactions is examined. If there is no reaction, the drug will be tested on the patient. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Hemmatpor, Zohreh
No. 7.2, First Floor, Unit 2, West 1st Arghavan St., Doniamali Blvd., 1st phase of andishe., Shahriar, Tehran.
Tehran Iran (Islamic Republic of) 3354462338 +98 21 6591 6096 z.hemmatpor@gmail.com Tehran University of Medical Sciences scientific Hemmatpor, Zohreh
No. 7.2, First Floor, Unit 2, West 1st Arghavan St., Doniamali Blvd., 1st phase of andishe., Shahriar, Tehran.
Tehran Iran (Islamic Republic of) 3354462338 +98 21 6591 6096 z.hemmatpor@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Hospitalization in the surgical ward Implantation of a peripheral venous catheter in the upper limb, in a place without signs of phlebitis The patient is alert and able to understand and describe pain Necessary desire and cooperation from the patient The age of the samples is between 18 and 60 years No diabetes No skin disorders and eczema Lack of sensitivity to peripheral venous catheter adhesive Lack of chemotherapy No acute infectious diseases 18 years 60 years Both Grade 2, 3 and 4 phlebitis Fever 180.8 Phlebitis and thrombophlebitis of other sites Prevention Placebo Intervention group: In the intervention group, Dorema Ammoniacum cream is used. To prepare Dorema Ammoniacum cream, 100 grams of Dorema Ammoniacum resin oleogum is weighed and ground. 1 liter of 70 degree alcohol is added to it. Clears after 48 hours. Add another liter of alcohol and strain it again after 48 hours. The filtered solution is concentrated by rotary rotation. The concentrated solution is placed in a vacuum oven to form a powder. 5 g of the powder with 20 cc of distilled water is placed in an ultrasonic bath for 15 minutes to obtain a uniform liquid. A uniform liquid is added to 100 g of the base cream and it is beaten evenly with an electric mixer to obtain a uniform cream. It is then packed in 50 g containers. 70% alcohol is used only for extraction and after drying the extract, nothing of alcohol remains in the extract. Before using the cream, a skin allergy test is performed, in which some cream is rubbed on the patient's arm and after For 20 minutes the position is examined for redness, rash and other allergic reactions, and if there is no reaction, the drug will be tested on the patient. The product is standardized by spectrophotometric method based on the amount of spirochete compounds of terpenoic chromium acid 2-4-dione. Ash essential oil is also isolated and its compounds are identified by GC-MS. According to the European Pharmacopoeia, skin-mucosal products do not need to be sterilized. Control group: The base cream is prepared by Farabi company and consists of Vaseline, glycerin, monostearate, beeswax, lanolin, stearic acid, alcohol, distilled water, triethanolamine. To prepare the placebo, the base cream is in 50 containers. It is warmly packaged. Before using the cream, a skin allergy test is performed, in which some cream is rubbed on the patient's arm, and after 20 minutes, the position for redness, rash and other allergic reactions is examined. If there is no reaction, the drug will be tested on the patient. Degree of phlebitis. Timepoint: Determining the degree of phlebitis at 12, 24, 36, 48, 60 and 72 hours after implantation of peripheral venous catheter and application of Dorema Ammoniacum cream. Method of measurement: The VIP Infusion Visual Scale Checklist for Phlebitis was developed to assess the position around the peripheral venous catheter for phlebitis and was rated from 0 (no phlebitis) to 5 (advanced thrombophlebitis). Evidence of phlebitis that can be observed and examined for scoring has been stated and action that is appropriate for that stage of phlebitis has been stated. Tehran University of Medical Sciences Approved 2020-10-20 Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences Tehran, Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery tehran Tehran Iran (Islamic Republic of)