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IRCT20221011056150N1 IRCT 2023-01-07 Iran University of Medical Sciences Evaluating the effect of Platelet-Rich Fibrin on the survival of Diced cartilage Evaluating the effectiveness of Platelet-Rich Fibrin on the survival of Diced cartilage in rhinoplasty candidate patients 2020-05-21 anticipated 40 Complete https://irct.ir/trial/66459 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are placed in one of the two groups of rhinoplasty without PRF (group A) or rhinoplasty with PRF (group B). Randomization is done based on the (RAND) function of Excel software and based on this, a table of random numbers is prepared, and patients are placed in groups A or B according to the rows of this table, Blinding description: Considering that the intervention is of surgical type, only the patients have been kept blind and the surgeon and clinical assessor and those responsible for data collection know about the grouping of the patients. 3 Rhinoplasty. Intervention 1: Intervention group: includes 20 rhinoplasty candidates who meet the inclusion criteria, whose order and type of intervention is randomly based on the (RND) function of Excel software. These patients receive diced cartilage mixed with platelet-rich fibrin during rhinoplasty. One year after the surgery, the cartilage is evaluated by ultrasound and evaluations by a skilled surgeon. Intervention 2: Control group: includes 20 rhinoplasty candidates who meet the inclusion criteria, whose order and type of intervention is randomly based on the (RND) function of Excel software. These patients receive diced cartilage without platelet-rich fibrin during rhinoplasty. One year after the surgery, the cartilage is evaluated by ultrasound and evaluations by a skilled surgeon. 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 Still undecided - no release schedule yet
public Elham Zahabi
No. 22/9 , North bahar St , west ferdous Blvd
Tehran Iran (Islamic Republic of) 1445613131 +98 21 4494 3270 zahabie71@gmail.com Iran University of Medical Sciences scientific Elham Zahabi
No. 22/9 , North bahar St , west ferdous Blvd
Tehran Iran (Islamic Republic of) 1445613131 +98 21 4494 3270 zahabie71@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Rhinoplasty candidate patients no limit no limit Both Hematologic diseases Treatment - Surgery Treatment - Drugs Intervention group: includes 20 rhinoplasty candidates who meet the inclusion criteria, whose order and type of intervention is randomly based on the (RND) function of Excel software. These patients receive diced cartilage mixed with platelet-rich fibrin during rhinoplasty. One year after the surgery, the cartilage is evaluated by ultrasound and evaluations by a skilled surgeon. Control group: includes 20 rhinoplasty candidates who meet the inclusion criteria, whose order and type of intervention is randomly based on the (RND) function of Excel software. These patients receive diced cartilage without platelet-rich fibrin during rhinoplasty. One year after the surgery, the cartilage is evaluated by ultrasound and evaluations by a skilled surgeon. Sonographic result. Timepoint: One year after surgery. Method of measurement: Ultrasound (cartilage viability). Clinical examination of skilled surgeon. Timepoint: One year after surgery. Method of measurement: Grading by the surgeon - Likert scale. Iran University of Medical Sciences Approved 2020-05-10 Ethics Committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)