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IRCT201302218177N6 IRCT 2013-06-29 Vice chancellor for research of Tehran University of Medical The effects of fetal fibroblast in skin wound healing The effects of Acellular Amniotic membrane loaded by cultured fetal fibroblast cells in split thickness skin wound healing 2013-06-22 anticipated 10 Complete https://irct.ir/trial/8626 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 1-2 Skin Wound. Intervention 1: Intervention 1: Coverage of the skin graft donor site with acellular amnion loaded with cultured fetal fibroblast cell. The dressing will be changed every other day till complete healing of the wound after 3 days. Intervention 2: Intervention 2: Coverage of the skin graft donor site with acellular amnion. The dressing will be changed every other day till complete healing of the wound after 3 days. Intervention 3: Control group: Coverage of the skin graft donor site with Vaseline gauze. The dressing will be changed every other day till complete healing of the wound after 3 days.
public Mohammad Javad Fatemi
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 mj-fatemi@sina.tums.ac.ir Hazrat Fatima hospital scientific Mohammad Javad Fatemi
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 mj-fatemi@sina.tums.ac.ir Hazrat Fatima Hospital Iran (Islamic Republic of) Laboratory inclusion criteria: 1. Pregnant women who are older than 18 years old that had to be aborted 2. Filling informed consent 3. Aborted fetus with the age of 11 to 14 weeks 4.Lack of infectious diseases (HIV-HBV-HCV) 5.Lack consumption of immune-suppressive and cytotoxic drugs during past 6 months Laboratory exclusion criteria: 1. Aborted fetus that is younger than 11 weeks or older than 14 weeks 2.Pregnant women who are younger than 18 years old Clinical inclusion criteria: 1.Patients with the age of 20 to 60 years old 2. Those who need skin graft surgery 3.The extent of surgical site wound 10-30% 4. Filling informed consent 5. Lack of co-morbidity Clinical exclusion criteria: 1.Under the age of 20 years and above 60 years 2.The extent of surgical site wound more than 30% and less than 10% 3.Lack of informed consent 8 years 60 years Both T14.1 Open wound of unspecified body region Treatment - Other Treatment - Other Treatment - Other Intervention 1: Coverage of the skin graft donor site with acellular amnion loaded with cultured fetal fibroblast cell. The dressing will be changed every other day till complete healing of the wound after 3 days. Intervention 2: Coverage of the skin graft donor site with acellular amnion. The dressing will be changed every other day till complete healing of the wound after 3 days. Control group: Coverage of the skin graft donor site with Vaseline gauze. The dressing will be changed every other day till complete healing of the wound after 3 days. Wound healing. Timepoint: Examination and photography on 3, 5, 7, 11, 13 and 15 days and 1 month after surgery - biopsy on 7 dayس after surgery. Method of measurement: Observation and Examination and Biopsy. Pain. Timepoint: Three, five, seven, nine, eleven, thirteen and fifteen days after surgery. Method of measurement: Visual Analogue Scale. Infection. Timepoint: Seven and fifteen days after surgery. Method of measurement: Examination, Wound Culture. Scar. Timepoint: Three and six months after surgery. Method of measurement: Vancouver Scar Scale. Vice chancellor for research of Tehran University of Medical Approved 2013-04-22 Ethics committee of Tehran University of Medical Sciences Central Department of Tehran University of Medical Sciences, Keshavarz Blvd, Tehran Tehran Iran (Islamic Republic of)