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IRCT20230429058021N1 IRCT 2023-05-22 Sina Mehr Fajr Co. Safety and effectiveness evaluations of amniotic membrane wound dressing AM Clinical trial of the decellularized amniotic membrane for dressing of skin wounds 2023-05-22 anticipated 60 Complete https://irct.ir/trial/69882 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: In each center, the samples are selected from consecutive patients using simple randomization method (tossing a coin). After that, the background characteristics of the patients in each group are evaluated, Blinding description: The patient is unaware of the type of dressing used in each part of the wound, that is, he does not know which dressing is the main group and which is the control group. On the other hand, the surgeon who performs the dressing, the experienced nurse who records the history, and the doctor who evaluates the treatment result are three separate people. In this way, photos and histories are prepared and coded according to the checklist of the intervention and wound control parts at the designated times by the nurse (who is independent from the dressing and evaluator) and the photos are taken by the evaluating doctor who is from The type of dressing used in each photo is unknown, it is checked and the results are recorded. N/A Patients with second degree skin burns. Intervention 1: Intervention group: After selecting the patients and obtaining written consent from the patient or his/her legal guardian, the wound after washing with normal saline is covered with the amniotic membrane product of the current study and three layers of sterile gauze are placed on it. If the wound has a lot of exudate, the dressing will be changed every day. In cases of less exudate, it is changed every three to five days. Intervention 2: Control group: After selecting the patients and obtaining written consent from the patient or his/her legal guardian, the wound after washing with normal saline is covered with the commercial amniotic membrane product (Baft Iranian) and three layers of sterile gauze are placed on it. If the wound has a lot of exudate, the dressing will be changed every day. In cases of less exudate, it is changed every three to five days. Yes - There is a plan to make this available What will be shared: The results obtained according to the CRF file, such as healing speed, wound size, redness, inflammation, fever, etc. during treatment. All the results are coded, each code identifies the patient's personal information. The patient's personal information will only be available to the project manager. When: The information that can be presented after the completion of the project and the analysis of the results will be presented in scientific journals or in the congress. To whom: Only respected project managers will have access to the results of the patient's personal information. The information of the results of the study will be available to all people without mentioning the patient in the form of a scientific article. It is worth mentioning that this study is for the approval of the production license of this product by Sina Mehr Fajr Mazandaran. Conditions: The information of this study will also be provided to the Food and Drug department of Mazandaran University of Medical Sciences or the medical equipment and supplies department of the Tehran Food and Drug Administration. Where to obtain: Respected executors of the plan How to obtain: After the end of this project, the results of the study will be published as a scientific paper and available online. Although someone needs the results in more detail, he can request scientific data (not the patient's person) from the author of the article through the email provided in the section responsible for the article. Comments:
public Amir Mellati
Payambar Azam Campus, 17th km, Farahabad Rd.
Sari Iran (Islamic Republic of) 4847193711 +98 11 3325 1034 amirmellati@gmail.com Mazandaran University of Medical Sciences scientific Mazaher Gholipourmalekabadi
Shahid Hemmat Highway Tehran
Tehran Iran (Islamic Republic of) 14496-14535 +98 21 8670 4614 mazaher.gholipour@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with skin wounds (second degree burn trauma) after entering the hospital. no limit no limit Both Cases such as having severe vascular lesions, active or latent infection, or uncontrolled infection at the wound site can prevent the effectiveness of this allograft. Oposamniohyl should not be used to treat lesions that do not have a definitive diagnosis. In patients with metabolic, heart, kidney, liver, blood, autoimmune or any other major diseases, this product should not be used without the permission of the attending physician. T21.2 Burn of second degree of trunk Treatment - Surgery Treatment - Surgery Intervention group: After selecting the patients and obtaining written consent from the patient or his/her legal guardian, the wound after washing with normal saline is covered with the amniotic membrane product of the current study and three layers of sterile gauze are placed on it. If the wound has a lot of exudate, the dressing will be changed every day. In cases of less exudate, it is changed every three to five days Control group: After selecting the patients and obtaining written consent from the patient or his/her legal guardian, the wound after washing with normal saline is covered with the commercial amniotic membrane product (Baft Iranian) and three layers of sterile gauze are placed on it. If the wound has a lot of exudate, the dressing will be changed every day. In cases of less exudate, it is changed every three to five days Time and size (area) of the wound according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation and measurement of wound area. Wound granulation according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation by a wound specialist. Redness, discharge, apparent infection, unpleasant odor and other inflammatory reactions according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation and examination of the patient by a specialist doctor. Pain level according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Examination of the patient by a specialist doctor. Check the fever according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Thermometer. Wound healing time. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination and visual inspection. Wound size. Timepoint: Every 3 days to 21 days. Method of measurement: Visual inspection and ruler. Redness and inflammation. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination and visual inspection. Pain. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination. Sina Mehr Fajr Co. Approved 2023-04-16 Ethics committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Valie-Asr Boulevard, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)