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IRCT20211010052721N3 IRCT 2022-10-22 Mashhad University of Medical Sciences Investigating the effect of autologous platelet factor in ear repair Investigating the effect of using autologous platelet factor in accelerating mastoidectomy repair with removal of the posterior wall and comparing it with the control group. 2020-11-21 anticipated 50 Complete https://irct.ir/trial/66017 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with ''www.randomization.com'' website will be done. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: The study subjects will be unaware of the intervention and control groups. In this study beacause placebo will be used in parallel with the drug, the participants will not know whether the drug or the placebo is being used. 2-3 Mastoidectomy. Intervention 1: Intervention group: In this group of patients, in addition to Gelfoam, from 4 to 8 cc of throat fibrin enriched with platelets (Iranian Blood Transfusion Organization, Mashhad, Iran) will be used which is placed in the middle ear area above and below. Intervention 2: Control group: In this group of patients, only 4 to 8 cc of Gelfoam (Blood Transfusion Organization of Iran, Mashhad, Iran) will be used which is placed in the area of the middle ear below and above. 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 The decision is made after the completion of the project.
public Navid Nourizadeh
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
Mashhad Iran (Islamic Republic of) 1394491388 009838451521 Nourizadehn@mums.ac.ir Mashhad University of Medical Sciences scientific Navid Nourizadeh
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
Mashhad Iran (Islamic Republic of) 1394491388 009838451521 Nourizadehn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction Performing mastoidectomy by removing the posterior wall no limit no limit Both Having anemia Complications during surgery such as facial paralysis Breastfeeding Pregnancy H95.1 Other disorders of ear and mastoid process following mastoidectomy Treatment - Drugs Treatment - Drugs Intervention group: In this group of patients, in addition to Gelfoam, from 4 to 8 cc of throat fibrin enriched with platelets (Iranian Blood Transfusion Organization, Mashhad, Iran) will be used which is placed in the middle ear area above and below. Control group: In this group of patients, only 4 to 8 cc of Gelfoam (Blood Transfusion Organization of Iran, Mashhad, Iran) will be used which is placed in the area of the middle ear below and above. The duration of epithelialization of the eardrum. Timepoint: At the beginning of the study (before the start of the intervention) and 14, 30 and 90 days after the use of autologous platelet factor. Method of measurement: Otoscopy with a microscope. Mashhad University of Medical Sciences Approved 2020-11-17 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)