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IRCT20180218038788N2 IRCT 2020-06-16 Artesh University of Medical Sciences effect of dry human amniotic membrane in wound healing comparison of the effectiveness of dry human amniotic membrane in secondary intention healing of full thickness and non-infected wounds of abdomen and genitalia following surgery or trauma in ICU patients 2020-01-21 anticipated 20 Complete https://irct.ir/trial/46005 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done from a computer-generated sequence(SAS software), concealed in sequentially numbered, sealed, opaque envelopes, and kept by the ward secretary, Blinding description: after explanation of study, all the participants are blind because patients divided to two groups by sealed envelops and same intervention was done for both groups but with different material. N/A wound. Intervention 1: Intervention group: On the first or second day after surgery or trauma, if the wound is not infectious, a dry human amniotic membranes are placed on the wound and dressing is performed. Intervention 2: Control group: On the first or second day after surgery or trauma, if the wound is not infectious, the dressing is done routinely without an amniotic membrane. Yes - There is a plan to make this available What will be shared: There is no further information When: There is no further information To whom: There is no further information Conditions: There is no further information Where to obtain: There is no further information How to obtain: There is no further information Comments:
public Amirhossein Rahavian
Shohada Tajrish Hospital, Shahrdari Ave., Tajrish Square, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8000 amirrahavian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Amirhossein Rahavian
Shohada Tajrish Hospital, Shahrdari Ave., Tajrish Square, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8000 amirrahavian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) age more than 30 y/o Any underlying problem that may interfere with the tissue repair process including Diabetes. Immune deficiency diseases. Connective tissue disorders. heavy smoking or any other lung or heart disease that disrupts the oxygen supply to the tissue Full thickness open wounds in the genital area and Perineum that due to inflammation, wound contamination or huge defect are not suitable candidates for primary healing Aforementioned wounds that were repaired once and again for various reasons including hematoma, High tension on the repair site, Inappropriate blood supply and ... has been restored and cannot be repaired in the second time Aforementioned wounds that are candidate for secondary intention based of physician opinion 30 years no limit Both active wound infection lack of consent form completion by patient patient death during study S31 Open wound of abdomen, lower back, pelvis and external genitals Treatment - Other Placebo Intervention group: On the first or second day after surgery or trauma, if the wound is not infectious, a dry human amniotic membranes are placed on the wound and dressing is performed. Control group: On the first or second day after surgery or trauma, if the wound is not infectious, the dressing is done routinely without an amniotic membrane. Wound healing time. Timepoint: 14-30-90 days. Method of measurement: physical examination by physician. Wound infection rate. Timepoint: 14-30-90 days. Method of measurement: wound culture. Hospital admission time. Timepoint: 14-30-90 days. Method of measurement: admission and discharge date. Artesh University of Medical Sciences Approved 2020-05-26 Ethics committee of AJA University of Medical Sciences Tehran, West Fatemi Ave., Shahid Etemadzade Ave., AJA University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)