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IRCT20190120042436N5 IRCT 2023-01-29 Yasouj University of Medical Sciences Comparative study of combined the effect of Cucurbita pepo L. oil and 1% silver sulfadiazine ointment on wound healing and severity of second degree burn pain Comparative study of combined the effect of Cucurbita pepo L. oil and 1% silver sulfadiazine ointment with the control group on wound healing and severity of second degree burn pain in children 2-7 years 2023-02-09 anticipated 98 Complete https://irct.ir/trial/68215 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible children are selected through non-probability (available) sampling, but they are assigned to one of the two groups of intervention exercises and the control group in the form of random block allocation. The random allocation of blocks will be in such a way that according to the number of studied groups, which consists of two groups consisting of group 1 (intervention) and group 2 (control), the number of blocks will be calculated based on the factorial law, that is, 2 = 1 * 2 = 2! . The possible arrangement modes of the participants from each group in each block are indicated by the label A representing group 1 (intervention), B representing group 2 (control). Therefore, there are 2 blocks for random allocation, where there are 2 participants in each block, one person from each group, but their order is different. Block sampling will continue until the number of samples is completed. It should be noted that since there are 2 samples in each block, the number of selected samples will be the same in both groups, Blinding description: In this study, the patients are informed that they may be placed in one of the intervention or control groups, and naturally they will receive the medicine related to the same group. In addition, the main researcher and the nurse who is responsible for the care of the patients, the person responsible for collecting the data and those who evaluate the outcome and the person responsible for the analysis will not know the type of intervention for each person or group. 3 Burn of second degree. Intervention 1: Intervention group: The studied patients are dressed with pumpkin seed oil by the researcher once a day for a period of 14 days. The experimental group is treated with pumpkin seed oil. In this way, after washing the wounds daily with normal saline, in second-degree superficial wounds that usually have a complete blister, without removing the blister in the experimental group, a layer of pumpkin seed oil with a diameter of 5 mm will be placed on the wound and It is a dressing. In a second degree deep wound where the blisters are usually destroyed, after removing the blisters and dead tissues and washing the wound surface with normal saline in a sterile way and placing a layer of pumpkin seed oil with a diameter of 5 mm on the wound, a bandage is applied. be made patients in six stages; The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of recovery and the fourteenth day after the start of treatment are evaluated, and the day of the clear start of epithelization and the start of the repair process will be recorded for each patient. To check the condition of the wound, they are evaluated during the study and every time the dressing is changed. If any of the samples stop participating in the research for some reason, they will be removed and other samples will be selected and replaced in their place. Also, the condition of the wound is checked for the presence of granulation tissue and epithelization every time the dressing is changed. If signs of infection are observed, the sample will be removed from the study and referred to the doctor for further treatment. In order to increase the accuracy and accuracy of the research, two observers (the researcher and the permanent nurse who changes the dressing) will be used before the study and compared in the observed position. In addition, in each session, with the consent of the patient, photographs are taken of the lesions and they are examined in terms of the healing process. In this study, patients, caregivers, researchers and the person responsible for the analysis will not know the type of intervention for each person or group. Intervention 2: Control group: The studied patients were dressed with 1% silver sulfadiazine by the researcher once a day for a period of 14 days. The control group is treated only with 1% silver sulfadiazine. In this way, after washing the wounds daily with normal saline, in second-degree superficial wounds that usually have a complete blister, without removing the blister in the control group, a layer of 1% silver sulfadiazine cream with a diameter of 5 mm will be placed on the wound. And it is bandaged. In a second degree deep wound where the blisters are usually destroyed, after removing the blisters and dead tissues and washing the wound surface with normal saline in a sterile way and placing a layer of pumpkin seed oil with a diameter of 5 mm on the wound, a bandage is applied. be made patients in six stages; The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of recovery and the fourteenth day after the start of treatment are evaluated, and the day of the clear start of epithelization and the start of the repair process will be recorded for each patient. To check the condition of the wound, they are evaluated during the study and every time the dressing is changed. If any of the samples stop participating in the research for some reason, they will be removed and other samples will be selected and replaced in their place. Also, the condition of the wound is checked for the presence of granulation tissue and epithelization every time the dressing is changed. If signs of infection are observed, the sample will be removed from the study and referred to the doctor for further treatment. In order to increase the accuracy and accuracy of the research, two observers (researcher and a permanent nurse changing the dressing) will be checked and compared before the study, in the observed position. In addition, in each session, with the consent of the patient, photographs are taken of the lesions and they are examined in terms of the healing process. In this study, patients, researchers, nurses and the person responsible for the analysis will not know the type of intervention for each person or group. Yes - There is a plan to make this available What will be shared: Part of the data related to the main outcome will be shared When: Access to data six months after completion of collection and results To whom: Access to data through academic institutions Conditions: Research works and references Where to obtain: Yasuj University of Medical Science, Faculty of Nursing How to obtain: Access after going through the relevant administrative procedures Comments:
public Mohsen Salari
Yasuj, next to Imam Sajjad Hospital,Educational Campus, nursing Faculty
Yasuj Iran (Islamic Republic of) 7591755418 +98 74 3323 4115 salarimo@yahoo.com Yasouj University of Medical Sciences scientific Hosein Sadeghi
Yasuj, next to Imam Sajjad Hospital, Educational Campus - Faculty of Medicine
Yasuj Iran (Islamic Republic of) 7591755418 +98 74 3323 0290 doctor.sadeghi@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) The cause of thermal burns Consent to participate in the study Age 2 to 7 years Second degree burn and below 20% and thermal type Burns in the hands and feet except the fingers Do not wash excessively with water and detergents Not having diseases that weaken the immune system The child's face is healthy and does not suffer from any congenital malformation, especially in the organs and face, and does not have trauma in the organs 2 years 7 years Both Lack of parental consent Creating an active infection at the site of the lesion Use of topical immunosuppressants within four weeks before starting treatment Local infection Any vascular disease of the brain, cardiovascular Patients needing a skin graft for treatment T30.2 Burn of second degree, body region unspecified Treatment - Drugs Treatment - Drugs Intervention group: The studied patients are dressed with pumpkin seed oil by the researcher once a day for a period of 14 days. The experimental group is treated with pumpkin seed oil. In this way, after washing the wounds daily with normal saline, in second-degree superficial wounds that usually have a complete blister, without removing the blister in the experimental group, a layer of pumpkin seed oil with a diameter of 5 mm will be placed on the wound and It is a dressing. In a second degree deep wound where the blisters are usually destroyed, after removing the blisters and dead tissues and washing the wound surface with normal saline in a sterile way and placing a layer of pumpkin seed oil with a diameter of 5 mm on the wound, a bandage is applied. be made patients in six stages; The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of recovery and the fourteenth day after the start of treatment are evaluated, and the day of the clear start of epithelization and the start of the repair process will be recorded for each patient. To check the condition of the wound, they are evaluated during the study and every time the dressing is changed. If any of the samples stop participating in the research for some reason, they will be removed and other samples will be selected and replaced in their place. Also, the condition of the wound is checked for the presence of granulation tissue and epithelization every time the dressing is changed. If signs of infection are observed, the sample will be removed from the study and referred to the doctor for further treatment. In order to increase the accuracy and accuracy of the research, two observers (the researcher and the permanent nurse who changes the dressing) will be used before the study and compared in the observed position. In addition, in each session, with the consent of the patient, photographs are taken of the lesions and they are examined in terms of the healing process. In this study, patients, caregivers, researchers and the person responsible for the analysis will not know the type of intervention for each person or group. Control group: The studied patients were dressed with 1% silver sulfadiazine by the researcher once a day for a period of 14 days. The control group is treated only with 1% silver sulfadiazine. In this way, after washing the wounds daily with normal saline, in second-degree superficial wounds that usually have a complete blister, without removing the blister in the control group, a layer of 1% silver sulfadiazine cream with a diameter of 5 mm will be placed on the wound. And it is bandaged. In a second degree deep wound where the blisters are usually destroyed, after removing the blisters and dead tissues and washing the wound surface with normal saline in a sterile way and placing a layer of pumpkin seed oil with a diameter of 5 mm on the wound, a bandage is applied. be made patients in six stages; The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of recovery and the fourteenth day after the start of treatment are evaluated, and the day of the clear start of epithelization and the start of the repair process will be recorded for each patient. To check the condition of the wound, they are evaluated during the study and every time the dressing is changed. If any of the samples stop participating in the research for some reason, they will be removed and other samples will be selected and replaced in their place. Also, the condition of the wound is checked for the presence of granulation tissue and epithelization every time the dressing is changed. If signs of infection are observed, the sample will be removed from the study and referred to the doctor for further treatment. In order to increase the accuracy and accuracy of the research, two observers (researcher and a permanent nurse changing the dressing) will be checked and compared before the study, in the observed position. In addition, in each session, with the consent of the patient, photographs are taken of the lesions and they are examined in terms of the healing process. In this study, patients, researchers, nurses and the person responsible for the analysis will not know the type of intervention for each person or group. Wound healing score of Bates-Jensen Wound Assessment Tool. Timepoint: The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of repair and the fourteenth day after the start of treatment. Method of measurement: Bates-Jensen Wound Assessment Tool for healing of burn. Pain severity. Timepoint: The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of repair and the fourteenth day after the start of treatment. Method of measurement: Face, Legs, Activity, Cry, Consolability scale (FLACC scale). Pain degeneration. Timepoint: The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of repair and the fourteenth day after the start of treatment. Method of measurement: Bates-Jensen Wound Assessment Tool. Yasouj University of Medical Sciences Approved 2023-01-04 Research Ethics Committees of Yasuj University of Medical Science Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad Province Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)