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IRCT20220808055641N1 IRCT 2022-09-11 Tehran University of Medical Sciences Investigating the effectiveness of PRP and Noncross linked hyaluronic acid in the treatment of atrophic burn scars. Comparing the effectiveness of PRP injection with Noncross-linked hyaluronic acid injection and PRP injection in combination with Noncross-linked hyaluronic acid in patients treated with CO2 fractional laser in the treatment of atrophic burn scars; A double-blind randomized clinical trial 2022-09-06 anticipated 10 Complete https://irct.ir/trial/65445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: The burn scar of all patients is divided into four parts and in a simple randomization and individually based on the random table of numbers, each of the parts is subjected to a therapeutic intervention from among the four mentioned interventions, and the recovery rate is as before and After, each area will be evaluated and then the improvement in the four mentioned areas will be compared, Blinding description: The participants in the study, as well as the physician evaluating the clinical outcome, as well as the statistician analyzing the data, are kept blind to the type of injection performed at each location. N/A burn atrophic scar. Intervention 1: Intervention group 1:Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. And one time at the beginning of the study and the other time, one month after the first time, it is injected as an intradermal injection in the place of the burn scar. Intervention 2: Intervention group 2: njection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells, along with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 1 cc ready-to-injectable syringes of Juviderm, which are injected intradermally for each person, at the site of the burn scar. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention 3: Intervention group3 : Injection of non-cross-linked hyaluronic acid with a volume of 2 cc in the form of 1 cc ready-to-injectable syringes of Juviderm company, which two 1 cc syringes for each person are injected intradermally at the site of the burn scar. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention 4: Control group: injection of 2 cc of injectable normal saline, including sodium chloride solution with a concentration of 0.9% of Ghazi Pharmaceutical Company, once at the beginning of the study and another time, one month after the first time, as an intradermal injection, at the site The burn scar is injected. Yes - There is a plan to make this available What will be shared: After the completion of the study, all patient data will be shared through the article after de-identification. When: Access to data starts immediately after the publication of the article. To whom: There are no restrictions on people's access to dataŁ… Conditions: There is no restriction on the type of data usage. Where to obtain: rasool-E-akram hospital, niyayesh Ave, satar khan Blvd, Tehran 00989198907445 alireza jafarzadeh alirezajafarzadeh8@gmail.com How to obtain: After receiving the email from the applicant, the data will be sent within a maximum of 6 months. Comments:
public Alireza Jafarzadeh
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
Tehran Iran (Islamic Republic of) 6567634523 +98 919 890 7445 Alirezajafarzadeh8@gmail.com Iran University of Medical Sciences scientific Alireza Jafarzadeh
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
Tehran Iran (Islamic Republic of) 13244357653 +98 919 890 7445 Alirezajafarzadeh8@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Existence of atrophic burn scar treated with CO2 fractional laser 18 years 50 years Both Age less than 18 years or more than 50 years Atrophic scar created in the last 6 months Conducting therapeutic intervention for atrophic scar in the last one month except CO2 fractional laser Bleeding and coagulation disorder pregnancy breastfeeding L90 Atrophic disorders of skin Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1:Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. And one time at the beginning of the study and the other time, one month after the first time, it is injected as an intradermal injection in the place of the burn scar. Intervention group 2: njection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells, along with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 1 cc ready-to-injectable syringes of Juviderm, which are injected intradermally for each person, at the site of the burn scar. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention group3 : Injection of non-cross-linked hyaluronic acid with a volume of 2 cc in the form of 1 cc ready-to-injectable syringes of Juviderm company, which two 1 cc syringes for each person are injected intradermally at the site of the burn scar. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Control group: injection of 2 cc of injectable normal saline, including sodium chloride solution with a concentration of 0.9% of Ghazi Pharmaceutical Company, once at the beginning of the study and another time, one month after the first time, as an intradermal injection, at the site The burn scar is injected. Improvement of burn atrophic scar. Timepoint: The beginning of the study and 1 month after the start of the study and 3 months after the start of the study. Method of measurement: vancouver scar scale;sonography;visioface;biometery;cutometery,physician global assessment score;patient global assessment score. Tehran University of Medical Sciences Approved 2022-08-13 Ethics committee of Tehran University of Medical Sciences No 6, Avesta Ave, Azadi Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)