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IRCT20210524051384N1 IRCT 2021-08-24 Deputy of Research and Technology, Guilan University of Medical Sciences Comparison of the effects of biological (amniotic) with traditional dressings in the treatment of deep second degree burn wounds 5-20% in less than 24 hours in patients admitted to the Velayat hospital Comparison of the effects of biological (amniotic) with traditional dressings in the treatment of deep second degree burn wounds 5-20% in less than 24 hours in patients admitted to the Velayat hospital 2021-09-23 anticipated 42 Complete https://irct.ir/trial/58057 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocking and allocation sequences will be done by the person not involved in the research to hide the patient's choice. The sample allocation ratio will be (1: 1) and will be divided into control and intervention groups. Then, based on the obtained blocks and in the order of allocation, the dressings will be placed on the patients of the control and intervention groups. In this study, blinding will not occur due to the different appearance of biological (amniotic) and traditional dressings. In this study, to assign patients to intervention and control groups, the limited randomization approach will be used in parallel with the block randomization method. We will consider random blocks of size 4. A table of random numbers (Random allocation software ) will be used to generate random numbers. N/A Acute burn. Intervention 1: biological dressing: For patients with grade 2 burns, in group A, after cleaning the burned surface and removing blisters and foreign objects from the burn site, washing with normal saline will be performed, and then biological dressing (amniotic fluid) will be served. The amniotic biological dressing is prepared from a pair of healthy mothers after a selective cesarean section at Al-Zahra Hospital. According to health protocols for mothers, blood samples are sent to the laboratory for testing for HCV, HBS, and HIV. The embryonic-related layers of the placenta are separated under the hood and then washed under sterile conditions with Ringer's solution. The amniotic layer is separated and transferred to cold sterilized containers (4 ° C). to remove the blood and other contaminants, it will be washed four times with normal saline. Once with 0.25% sodium hypochlorite solution, and washed again with normal saline. Then, the samples are transferred to sterile containers and refrigerated. When placing the amniotic membrane, care should be taken; that the underlying layers, which can reproduce, should be placed on the wound. Intervention 2: B) Traditional dressings: In group B, dressings will be applied in a traditional and daily manner according to the protocol of the Velayat hospital. After washing the wound with normal saline and debridement if necessary, ointments (Flamazine, Adiazine ،Mafenaide, Sulfamylon) are applied to the wound and then with plain gas. Will be covered and dressed. 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 I haven't decided yet - the release schedule is still unknown
public Ammirmohammad Gholipour
Velayat Hospital, Namjoo St, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4193713191 +98 13 3336 8860 Velayathospital@gmail.com Guilan University Of Medical Sciences scientific Dr Mohammadreza Mobayen
Namjoo St, Velayat Hospital, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4193713191 +98 13 3336 8860 Maziar.mobayen@gmail.com Guilan university of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Grade 2 burns Burns that are greater than 20 to 25 percent Admission less than 24 hours from the occurrence of burns Thermal burns with boiling water or flammable substances No underlying diseases such as diabetes, immune system deficiency, connective tissue disease, kidney disease, liver disease and hepatitis, etc. Satisfaction of participating in the study 18 years 60 years Both Age over 60 years Patients who died during the study Dissatisfaction with continuing the study Impossibility to follow the patient treatment process T30 Burn and Corrosion, Body Region Unspecified Treatment - Other Treatment - Other biological dressing: For patients with grade 2 burns, in group A, after cleaning the burned surface and removing blisters and foreign objects from the burn site, washing with normal saline will be performed, and then biological dressing (amniotic fluid) will be served. The amniotic biological dressing is prepared from a pair of healthy mothers after a selective cesarean section at Al-Zahra Hospital. According to health protocols for mothers, blood samples are sent to the laboratory for testing for HCV, HBS, and HIV. The embryonic-related layers of the placenta are separated under the hood and then washed under sterile conditions with Ringer's solution. The amniotic layer is separated and transferred to cold sterilized containers (4 ° C). to remove the blood and other contaminants, it will be washed four times with normal saline. Once with 0.25% sodium hypochlorite solution, and washed again with normal saline. Then, the samples are transferred to sterile containers and refrigerated. When placing the amniotic membrane, care should be taken; that the underlying layers, which can reproduce, should be placed on the wound. B) Traditional dressings: In group B, dressings will be applied in a traditional and daily manner according to the protocol of the Velayat hospital. After washing the wound with normal saline and debridement if necessary, ointments (Flamazine, Adiazine ،Mafenaide, Sulfamylon) are applied to the wound and then with plain gas. Will be covered and dressed. Average recovery time. Timepoint: daily. Method of measurement: Based on disease course / percentage. Vice-Chancellor for Research, Guilan University of Medical Sciences Approved 2021-07-28 Research Ethics Committees Of Guilan University Of Medical Sciences Guilan University Of Medical Science Rasht Guilan Iran (Islamic Republic of)