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IRCT20221116056518N1 IRCT 2022-11-29 Rasht University of Medical Sciences Facial abrasions and amniotic membrane HAM The effect of traditional dressing and aminiotic dressing on facial abrasion repair: a randomized control trial 2022-11-22 anticipated 44 Complete https://irct.ir/trial/66878 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, in order to allocate patients to intervention and control groups, resticted randomization approach will be used in parallel with block randomization method. We will consider the blocks as a 4-size random. The allocation ratio of samples will be (1:1) and will be in two groups of control and intervention. Then, based on the obtained blocks and sequencing, allocation of dressings will be placed on patients in the control and intervention group. To generate random numbers, various packages in R software will be used. 4 Facial abrasion. Intervention 1: Intervention group: This study is a prospective cohort consisting of 24 patients with ulcers, which will be conducted by the Department of Oral and Maxillofacial Surgery (OMFS) of Porsina Hospital during the year 1401. The method of implantation used (conventional or amniotic membrane) will be explained in detail to each patient individually, including advantages, disadvantages, and written informed consent will be obtained from all. Patients will be randomly divided into 2 groups (12 people in each group). A group of people receiving standard or traditional treatment (control group). and another group of people whose wound will be covered with amniotic membrane and treated (intervention group). Permission for all stages of this study will be obtained from the university ethics committee. In the intervention group, after cleaning the wound surface with normal saline serum and separating foreign bodies (if any), washing with 0.9% normal saline and then biological dressing (amnion) will be done. Amnion biological surrogate (mother's pair) is used for non-diseased and healthy mothers after elective caesarean section in Al-Zahra Hospital. According to health protocols for mothers, blood samples are sent to the laboratory to check for HCV, HBS and HIV. The embryonic layers of the placenta are separated under the hood and then washed under sterile conditions with Ringer's solution, and the amnion layer is separated and transferred to sterile containers (4°C). In order to remove blood and other contaminants, it is washed four times with normal saline and then once with 0.25% sodium hypochlorite solution and washed again with normal saline. Then the samples are transferred to the refrigerator in sterile containers.To rule out bacterial contamination, routine cultures are performed from the stored membranes. Amniotic curtains should be prepared no later than 12 hours after delivery, and after freezing and drying, they can be stored for about a year. Regarding the placement of the amnion membrane, care must be taken to ensure that the lower layer, which has the ability to multiply, is placed on the wound and that the tissue is not placed on the wound from behind. Then dressing will be done for 2 weeks on days 4, 7 and 14. When the amniotic membrane is placed on the wound, it will stick to itself and there will be no need for stitches. Pieces of amniotic membrane measuring 1-2 x 3-5 cm can be selected depending on the size and extent of the wound.Patients will be examined by an OMFS specialist at intervals of 1 month, 2 months, and 6 months, and the thickness of the scars will be evaluated with the Vancouver scar scale (VSS). Also, the rating of itching from 0 (no itching) to 4 (severe itching) will be done by the same expert. Intervention 2: Control group: In this study, the control group will receive standard treatment. This treatment includes using gentamicin ointment or tetracycline for decontamination, sutures if necessary, and then covering wounds with wet-to-dry dressing in this method after one week, the dressing is removed and after pulling the sutures, the person will be prescribed anti-scar ointment. 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 The data is not enough
public Rahman Hosseiny kariz omar
Namjo St, Velayat Hospital
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 S.rahman.hosseiny@gmail.com Rasht University of Medical Sciences scientific Rahman Hosseiny kariz omar
Namjoo street
Rasht Iran (Islamic Republic of) 4193713194 +98 21 7795 8432 s.rahman.hosseiny@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) ... Emergency department admission less than 24 hours after the incident Satisfaction with participating in the study Ages between 18 and 60 Facial ulcers at least 15% of the surface of the skin on the patient's face 18 years 60 years Both late referral history of heart, kidney, diabetes and other metabolic organs (e.g. thyroid, pituitary, etc.) T14.0 Superficial injury of unspecified body region Treatment - Surgery Treatment - Surgery Intervention group: This study is a prospective cohort consisting of 24 patients with ulcers, which will be conducted by the Department of Oral and Maxillofacial Surgery (OMFS) of Porsina Hospital during the year 1401. The method of implantation used (conventional or amniotic membrane) will be explained in detail to each patient individually, including advantages, disadvantages, and written informed consent will be obtained from all. Patients will be randomly divided into 2 groups (12 people in each group). A group of people receiving standard or traditional treatment (control group). and another group of people whose wound will be covered with amniotic membrane and treated (intervention group). Permission for all stages of this study will be obtained from the university ethics committee. In the intervention group, after cleaning the wound surface with normal saline serum and separating foreign bodies (if any), washing with 0.9% normal saline and then biological dressing (amnion) will be done. Amnion biological surrogate (mother's pair) is used for non-diseased and healthy mothers after elective caesarean section in Al-Zahra Hospital. According to health protocols for mothers, blood samples are sent to the laboratory to check for HCV, HBS and HIV. The embryonic layers of the placenta are separated under the hood and then washed under sterile conditions with Ringer's solution, and the amnion layer is separated and transferred to sterile containers (4°C). In order to remove blood and other contaminants, it is washed four times with normal saline and then once with 0.25% sodium hypochlorite solution and washed again with normal saline. Then the samples are transferred to the refrigerator in sterile containers.To rule out bacterial contamination, routine cultures are performed from the stored membranes. Amniotic curtains should be prepared no later than 12 hours after delivery, and after freezing and drying, they can be stored for about a year. Regarding the placement of the amnion membrane, care must be taken to ensure that the lower layer, which has the ability to multiply, is placed on the wound and that the tissue is not placed on the wound from behind. Then dressing will be done for 2 weeks on days 4, 7 and 14. When the amniotic membrane is placed on the wound, it will stick to itself and there will be no need for stitches. Pieces of amniotic membrane measuring 1-2 x 3-5 cm can be selected depending on the size and extent of the wound.Patients will be examined by an OMFS specialist at intervals of 1 month, 2 months, and 6 months, and the thickness of the scars will be evaluated with the Vancouver scar scale (VSS). Also, the rating of itching from 0 (no itching) to 4 (severe itching) will be done by the same expert. Control group: In this study, the control group will receive standard treatment. This treatment includes using gentamicin ointment or tetracycline for decontamination, sutures if necessary, and then covering wounds with wet-to-dry dressing in this method after one week, the dressing is removed and after pulling the sutures, the person will be prescribed anti-scar ointment. The intensity of itching. Timepoint: (days 4, 7, 14). Method of measurement: Itching ratings from 0 (no itching) to 4 (severe itching) will be done by the same specialist. Degree of pain. Timepoint: (days 4, 7, 14). Method of measurement: Pain Score on a scale of one to ten by patients. Rasht University of Medical Sciences Approved 2022-11-09 Ethics committee of Guilan University of Medical Sciences namjoo street, rasht, guilan Rasht Guilan Iran (Islamic Republic of)