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IRCT20150715023216N16 IRCT 2023-11-06 Esfahan University of Medical Sciences A comparative study of the local effect of Aloe Vera gel with cold and warm compress on the lower leg after coronary artery bypass surgery A comparative study of the local effect of Aloe Vera gel with cold and warm compress on ecchymosis of the lower leg after coronary artery bypass surgery 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72489 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The number of 60 patients who are candidates for coronary artery bypass surgery in Chamran Hospital according to the entry criteria, with a gradual method based on the order of referrals with random allocation (using a coin toss) in group A (local effect of aloe vera gel) or group B ( use of cold and warm compresses) or control are placed. Then, the subjects in each group are randomly selected in order to determine the right or left leg for intervention, using two envelopes containing number 1 (intervention) and number 2 (control) inside a box, and based on the desired number, The surgical incision site of the patient's legs is allocated in the intervention leg with aloe vera and the control leg. The same procedure is done for the patient in group B. In groups A and B, one foot of the patient is treated and the other foot is considered as control. N/A Ecchymosis. Intervention 1: Intervention group: The first stage of intervention in group A (local effect of aloe vera gel) is performed before dressing the wound in the operating room. In the opposite leg, routine intervention is performed, i.e. washing the wound with normal saline and dressing with sterile gauze and adhesive and bandaging. This procedure continues for 6 days. Photographs are taken of the desired position (legs of both legs) (days 2, 5, 7, 10 and 30). On the 10th and 30th days, in the office of Dr. Mohsen Mir Mohammad Sadeghi, photographs of the patient's legs are taken and the area of ​​hemorrhage is calculated using image j software.The aloe vera gel used in this research is prepared by Reyhan Naqsh Jahan Pharmaceutical Company based on the United States Pharmacopoeia (USP), which is packed in sterile containers under sterile conditions and in compliance with hygiene precautions with sterile gloves. Intervention with aloe vera gel in The first to sixth days are done in the inpatient departments. In group A, the first intervention stage is performed in the operating room by Dr. Mohsen Mir Mohammad Sadeghi's dedicated assistant with sterile aloe vera gel that has been prepared in advance on the affected leg, and then dressing is performed with sterile gauze, glue, and bandaging. Dressing with sterile gauze, glue and bandaging is performed on the control legThen, on a daily basis, standard methods of surgical wound care, such as washing with normal saline and performing sterile dressings once a day, elastic bandages for both legs of patients, are performed by nurses working in the special care and surgery department. Both groups A and B, one leg of the patient is treated and the other leg is considered as control. Intervention 2: In group B (use of hot and cold compresses), one of the legs is placed under a cold compress in the first 48 hours after the surgery, and then on the third to sixth days of the surgery, a warm compress is applied, and in the opposite leg, a routine intervention, i.e. washing the wound with Normal saline serum and dressing is done with sterile gauze and adhesive and bandaging. This procedure continues for 6 days. Photographs are taken of the desired position (legs of both legs) (days 2, 5, 7, 10 and 30). On the 10th and 30th days, in the office of Dr. Mohsen Mir Mohammad Sadeghi, photographs are taken of the patient's legs and the area of ​​hemorrhage is calculated using image j software.Intervention with cold compresses in the inpatient wards, on the first two days of surgery, a gel pack (HEPSUN) that has been placed in the freezer an hour before is placed around the wound with a gauze cover for 10 minutes, and in the next four days in the inpatient wards ( Day 3, 4, 5, 6) A warm compress in the form of a jelly pack (HEPSUN) that we have previously placed in the microwave for one minute or in boiling water for 10 minutes, is placed in a cloth bag and placed around the wound on the control leg. Dressing is done with sterile gauze, glue and bandaging.On a daily basis, standard methods of surgical wound care, such as washing with normal saline and performing sterile dressings once a day, elastic bandages for both legs of patients are performed by nurses working in the special care and surgery department. Both groups A and B, one leg of the patient is treated and the other leg is considered as control. Intervention 3: Control group: In this research, the control group is the same leg opposite to the intervention leg in intervention number 1 and 2. In both groups A and B, based on randomization, using a box, one leg of the intervention patient and the other leg It is considered as the control leg. In the control group, the routine intervention is washing the wound with normal saline and dressing with sterile gauze, glue and bandaging. This procedure continues for 6 days. Photographs are taken of the target position (legs of both legs) (days 2, 5, 7, 10 and 30) and the area of ​​hemorrhage is calculated using image j software. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ahmad Gadami
HezarJerib Street , Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7583 ghadami@mui.ac.ir Esfahan University of Medical Sciences scientific Zahra Shahriar Panah
HezarJerib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3028 kosarhasan.shahryar06@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Informed and written consent to participate in the study Coronary bypass surgery removal of vascular grafts from both legs no limit no limit Both history of skin disease emergency surgery allergy to aloe vera drug use or continuous alcohol or cigar use history of vascular disease such as Raynaud's, Berger's, etc. history of drug, food or allergy coagulopathy or the need to take anti-coagulant drugs Prevention Prevention Prevention Intervention group: The first stage of intervention in group A (local effect of aloe vera gel) is performed before dressing the wound in the operating room. In the opposite leg, routine intervention is performed, i.e. washing the wound with normal saline and dressing with sterile gauze and adhesive and bandaging. This procedure continues for 6 days. Photographs are taken of the desired position (legs of both legs) (days 2, 5, 7, 10 and 30). On the 10th and 30th days, in the office of Dr. Mohsen Mir Mohammad Sadeghi, photographs of the patient's legs are taken and the area of ​​hemorrhage is calculated using image j software.The aloe vera gel used in this research is prepared by Reyhan Naqsh Jahan Pharmaceutical Company based on the United States Pharmacopoeia (USP), which is packed in sterile containers under sterile conditions and in compliance with hygiene precautions with sterile gloves. Intervention with aloe vera gel in The first to sixth days are done in the inpatient departments. In group A, the first intervention stage is performed in the operating room by Dr. Mohsen Mir Mohammad Sadeghi's dedicated assistant with sterile aloe vera gel that has been prepared in advance on the affected leg, and then dressing is performed with sterile gauze, glue, and bandaging. Dressing with sterile gauze, glue and bandaging is performed on the control legThen, on a daily basis, standard methods of surgical wound care, such as washing with normal saline and performing sterile dressings once a day, elastic bandages for both legs of patients, are performed by nurses working in the special care and surgery department. Both groups A and B, one leg of the patient is treated and the other leg is considered as control. In group B (use of hot and cold compresses), one of the legs is placed under a cold compress in the first 48 hours after the surgery, and then on the third to sixth days of the surgery, a warm compress is applied, and in the opposite leg, a routine intervention, i.e. washing the wound with Normal saline serum and dressing is done with sterile gauze and adhesive and bandaging. This procedure continues for 6 days. Photographs are taken of the desired position (legs of both legs) (days 2, 5, 7, 10 and 30). On the 10th and 30th days, in the office of Dr. Mohsen Mir Mohammad Sadeghi, photographs are taken of the patient's legs and the area of ​​hemorrhage is calculated using image j software.Intervention with cold compresses in the inpatient wards, on the first two days of surgery, a gel pack (HEPSUN) that has been placed in the freezer an hour before is placed around the wound with a gauze cover for 10 minutes, and in the next four days in the inpatient wards ( Day 3, 4, 5, 6) A warm compress in the form of a jelly pack (HEPSUN) that we have previously placed in the microwave for one minute or in boiling water for 10 minutes, is placed in a cloth bag and placed around the wound on the control leg. Dressing is done with sterile gauze, glue and bandaging.On a daily basis, standard methods of surgical wound care, such as washing with normal saline and performing sterile dressings once a day, elastic bandages for both legs of patients are performed by nurses working in the special care and surgery department. Both groups A and B, one leg of the patient is treated and the other leg is considered as control. Control group: In this research, the control group is the same leg opposite to the intervention leg in intervention number 1 and 2. In both groups A and B, based on randomization, using a box, one leg of the intervention patient and the other leg It is considered as the control leg. In the control group, the routine intervention is washing the wound with normal saline and dressing with sterile gauze, glue and bandaging. This procedure continues for 6 days. Photographs are taken of the target position (legs of both legs) (days 2, 5, 7, 10 and 30) and the area of ​​hemorrhage is calculated using image j software. Average area of ​​Ecchymosis. Timepoint: Days 2, 5, 7, 10 and 30 after coronary artery bypass surgery. Method of measurement: The program for determining the area of ​​j image and A30s phone camera. Esfahan University of Medical Sciences Approved 2023-09-04 Ethical Committee of Isfahan University of Medical Sciences Hezarjerib street, Isfahan,Iran Isfahan Isfehan Iran (Islamic Republic of)