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IRCT20210705051792N1 IRCT 2021-11-01 Esfahan University of Medical Sciences The effect of amniotic membrane in compare of Agcoat in healing of burn wounds The effect of amniotic membrane in healing of burn wounds in comparison with Ag coat dressing in the burned patients in Isfahan burn center 2021-07-23 anticipated 25 Complete https://irct.ir/trial/57394 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this study random sequence generation perform as minimization and for this manner initially the first case allocated to the first group and the second case also allocated to another group. According to the features of each cases a matched case also choice and include to the groups. For concealment, the cases will be added as lottery, Blinding description: Before transfer to the operation room. It is explained for the patients that their burn ulcer will be dressed as one of two formal manner. In operating room after allocation of each cases to groups finally, dressing will be done. Even after surgery, the patients do not aware of dressing type. In day 7, the patients` dressing will be changed by a nurse who do not participate in the study and the patient will be refer to a researcher(who do not aware of dressing type) for evaluation of variables and these variables will be send for analysis. N/A Burn. Intervention 1: Control group: In this group of patients, after initial resuscitation of burns, in the operating room, according to the extension of the burn, for one session or more, the burnt tissues will be debrided to reach a viable level. The burn wound will be covered by the Ag-coat dressing -Emad brand (which is the brand used by the hospital) as a standard and accepted treatment. Normally, a silver dressing is effective for 7 to 10 days, after which time it will be removed and based on the wound condition, a decision is made on how to continue the treatment, including repetition of the Ag-coat dressing, skin graft, or regular dressing. Finally, three, six and twelve months after the onset of burn, the patient's wound is evaluated according to clinical criteria as well as the Vancouver chart. Intervention 2: Intervention group: In this group of patients, after initial resuscitation of burns, in the operating room, based on the extension of the burn, for one session or more, the burnt tissues will be debrided to reach a viable level. The Life Cell brand (which is the brand used by the hospital) is covered as a new treatment. The amniotic dressing is usually absorbed within 5 to 7 days, after which time the condition of the wound is decided on how to continue the treatment, including skin grafts or regular dressings. Finally, three months and six months after the onset of burn, the patient's wound is evaluated according to clinical criteria as well as the Vancouver chart. Yes - There is a plan to make this available What will be shared: Except of Personal Information of patients all of other is reachable When: Every 3 months To whom: Academic Researcher Conditions: Academic Research Where to obtain: Study Correspondent How to obtain: Request by E-Mail Comments:
public Amin Ghanee Anaraki
Second Floor, Savaneh hospital, Kave
Isfahan Iran (Islamic Republic of) 8138894948 +98 31 3345 7670 aminghaneei@yahoo.com Esfahan University of Medical Sciences scientific Majid Kalbasi Gharavi
Second Floor, Savaneh hospital, Kave
Isfahan Iran (Islamic Republic of) 8138894948 +98 31 3345 7670 kalbasimajid@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Second Degree or More Burn Patient informed consent to participate in the study 1 year 60 years Both Associated Trauma Associated Chronic Illness Pregnancy Lactation T30.0 Burn of unspecified body region, unspecified degree Treatment - Other Treatment - Other Control group: In this group of patients, after initial resuscitation of burns, in the operating room, according to the extension of the burn, for one session or more, the burnt tissues will be debrided to reach a viable level. The burn wound will be covered by the Ag-coat dressing -Emad brand (which is the brand used by the hospital) as a standard and accepted treatment. Normally, a silver dressing is effective for 7 to 10 days, after which time it will be removed and based on the wound condition, a decision is made on how to continue the treatment, including repetition of the Ag-coat dressing, skin graft, or regular dressing. Finally, three, six and twelve months after the onset of burn, the patient's wound is evaluated according to clinical criteria as well as the Vancouver chart. Intervention group: In this group of patients, after initial resuscitation of burns, in the operating room, based on the extension of the burn, for one session or more, the burnt tissues will be debrided to reach a viable level. The Life Cell brand (which is the brand used by the hospital) is covered as a new treatment. The amniotic dressing is usually absorbed within 5 to 7 days, after which time the condition of the wound is decided on how to continue the treatment, including skin grafts or regular dressings. Finally, three months and six months after the onset of burn, the patient's wound is evaluated according to clinical criteria as well as the Vancouver chart. The Vancouver Scar Scale. Timepoint: First week, First month, Third month, Sixth Month. Method of measurement: According to Chart and Scale between 0-13. Hospitalization. Timepoint: From admission to discharge. Method of measurement: The days according to hospitalization file since the first day to the discharge day. Treatment cost. Timepoint: Admission Duration. Method of measurement: Cost in Rials based on the final bill of the hospital. Esfahan University of Medical Sciences Approved 2021-06-25 Ethics committee of isfahan University of Medical Sciences Hezar Jarib Ave., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)