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IRCT20200615047782N1 IRCT 2020-07-09 Zanjan University of Medical Sciences Effect of Amniotic Membrane Dressing in Donor Graft Site Comparison of Outcomes of Amniotic Membrane Dressing with Conventional Dressing in Donor Graft Site of Patients with Donor Site of Patients Admitted in Mousavi Hospital, Zanjan 2020-07-22 anticipated 36 Complete https://irct.ir/trial/49329 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will assign participants in study group using random blocks (each block size =4). Considering A and B as interventions for participants, we could have six blocks each have 2 A and 2 B (AABB, ABAB, ABBA, BABA, BBAA, BAAB). Ten block will be selected randomly (by rand function of Microsoft Excel) and we will recruits the participants according to final order. N/A Patients suffered thermal burns in need skin graft. Intervention 1: Intervention group: the intervention sites with a thickness of 0.4 to 0.6 mm are given using an electric dermatome with the same level of oxidation; Bleeding is controlled using epinephrine 1 in 50,000 with sterile gauze. One of the donor sites is randomly covered with an amniotic membrane. Amniotic membrane is taken from sero negative mothers who accepted to deliver their tissue as Volunteer. Then biologic dressing is covered by strile gauze. Intervention 2: Control group: The control group of control locations are both given a thickness of 0.4 to 0.6 mm using an electric dermatome with equal levels in both groups of oxions; Bleeding is controlled using epinephrine 1 in 50,000 with sterile gauze. One of the donor sites is accidentally covered with ordinary dressing, ie Vaseline gas (control group).In the control group, the cover is done directly with Vaseline gas. In the control group, the dressing is done with Vaseline gas and it will not be touched for 5 days. Yes - There is a plan to make this available What will be shared: Only part of the data, such as the original or similar information, can be shared When: Start the access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Only scientific use of data is possible Where to obtain: Salman sotoudeh Salman_1238@yahoo.com How to obtain: Data files will be received by the applicant within a maximum of three days Comments:
public Mohammad Hosein Moghimi
Mousavi hospital, Gavazang road
Zanjan Iran (Islamic Republic of) 1123456789 +98 24 3310 0001 Mohammadhosein_moghimi@yahoo.com Zanjan University of Medical Sciences scientific Mohammad Hosein Moghimi
Mousavi hospital, Gavazang road
Zanjan Iran (Islamic Republic of) 1123456789 +98 24 3313 0001 Mohammadhosein_moghimi@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with second- or third-degree burns or patients who need a semi-thick skin graft for any other reason and have a donor site Donor location in the limbs No injuries other than burns General physical and mental health Age between 7 years and 60 years Other conditions, such as trauma, are less than 40 percent of the wound and are on the limb and need to be removed 7 years 60 years Both Patients with blood-borne viral infections including hepatitis B and C and HIV Dissatisfaction of patients to enter the study Lack of follow-up ability Presence of any cerebrovascular, cardiovascular, endocrine, liver and kidney diseases; Pregnancy History of alcohol and drug abuse Concomitant use of antibiotics (orally and topically) Concomitant use of steroids or immunosuppressive drugs Infected patients at the donor site X09 Exposure to unspecified smoke, fire and flames Treatment - Other Treatment - Other Intervention group: the intervention sites with a thickness of 0.4 to 0.6 mm are given using an electric dermatome with the same level of oxidation; Bleeding is controlled using epinephrine 1 in 50,000 with sterile gauze. One of the donor sites is randomly covered with an amniotic membrane. Amniotic membrane is taken from sero negative mothers who accepted to deliver their tissue as Volunteer. Then biologic dressing is covered by strile gauze. Control group: The control group of control locations are both given a thickness of 0.4 to 0.6 mm using an electric dermatome with equal levels in both groups of oxions; Bleeding is controlled using epinephrine 1 in 50,000 with sterile gauze. One of the donor sites is accidentally covered with ordinary dressing, ie Vaseline gas (control group).In the control group, the cover is done directly with Vaseline gas. In the control group, the dressing is done with Vaseline gas and it will not be touched for 5 days. Scar percentage. Timepoint: The amount of scar on the fifth, fourteenth, and finally thirty-sixth days is evaluated as outpatient in the clinic by the relevant professor and its amount is recorded with a qualitative scale of 4 items: excellent, good, average, weak. Method of measurement: A measure of the body's scar level that is measured objectively. Healing rate. Timepoint: The time required for wound healing on the fifth, fourteenth, and finally 30th days of the clinic is evaluated on an outpatient basis by the relevant professor and its amount is recorded with a qualitative scale of 4 items: excellent, good, average, weak. Method of measurement: Healed: the wound area where the medicine wasapplied is completely healed ObviouslyEffective:70 % of the wound is healed Effective: over 30 % of the wound is healed Ineffective: the effective standard is not met. Zanjan University of Medical Sciences Approved 2020-04-29 Zanjan University of Medical Sciences Ethics Committee Ayatollah Mousavi Hospital Zanjan Zanjan Iran (Islamic Republic of)