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IRCT20220608055103N1 IRCT 2022-10-04 Rasht University of Medical Sciences tympanoplasty results using gelfoam block , autologus fat and mix of fat and gelfoam in Chronic Otitis Media Comparison of tympanoplasty results using gelfoam block support, autologus fat blocks and mix of fat and gelfoam blocks in Chronic Otitis Media: A Clinical Trial studyl 2022-07-23 anticipated 96 Complete https://irct.ir/trial/65181 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random allocation in 3 groups is based on random blocks, the sequence of which will be determined based on Table of random numbers. The list of this sequence of samples in 3 groups will be kept in the ENT research center in a sealed envelope and will be read gradually after the start of the study based on the inclusion criteria of the patients. Then, according to the patient group based on randomization, on the graft and in the area of the perforation connection with the graft, gelfoam is used in group A, and fat block in group B, and the combination of gelfoam and fat block pressed together is used in group C. The external ear canal is packed by Gelfoam in all 3 groups, Blinding description: The method of random allocation in 3 groups is based on random blocks, the sequence of which will be determined based on Table of random numbers. The list of this sequence of samples in 3 groups will be kept in the ENT research center in a sealed envelope and will be read gradually after the start of the study based on the inclusion criteria of the patients. After collecting the patients according to the random block, the participants are assigned to one of the groups A to c. Patients are not aware of their allocation to treatment groups. Based on the group mentioned in the received envelope, the treating doctor performs one of the treatment measures for the patient. The evaluation of the eardrum transplant result is done one month later by a specialist assistant who The patients are unaware of the therapeutic action taken. The follow-up of the patients is carried out for up to one month by the attending physician who is not aware of the therapeutic action taken. 3 Chronic Otitis Media. Intervention 1: Intervention group: , gelfoam is used in group A. Intervention 2: Intervention group: Fat block is used in group B.In order to prepare fat blocks, about 0.5 to 1 cubic centimeter is removed from the same place of skin incision and from the fat under the skin, and it is pressed and dried by Fat Presser. Intervention 3: Intervention group: In group C, a combination of gelfoam and fat block pressed together is used. In this group, along with the piece of fat, the same amount of Gelfoam is placed in the Fat Presser and they are pressed and dried together.Then they are cut into blocks and small pieces of 2 x 3 mm by a surgical knife. Yes - There is a plan to make this available What will be shared: In the case of individual patients data, all potential data will be shared after de-identifying individuals. The result of the clinical study will be published in the form of an article When: The access period starts 6 months after publication of the results. To whom: All researchers Conditions: for secondary data analysis and meta-analysis Where to obtain: Dr. shadman nemati, Otorhinolaryngology Research Center. Amiralmomenin Hospital , 17 Shahrivar Street. Bank Melli Square. Rasht.Postal code: 4139638459 -Tell: 01333225242- Mobile: 09111370488- Email: drshadmannemati_ent@yahoo.com How to obtain: After receiving the applicant's request and a brief statement of the protocol in which the mentioned information is used, a Preliminary review will be done and the information will be sent to the researcher within 2 weeks Comments:
public Shadman Nemati
17 shahrivar street, bank melli square, Amiralmomenin Hospital
Rasht Iran (Islamic Republic of) 4139638459 +98 13 3322 5242 drshadmannemati_ent@yahoo.com Rasht University of Medical Sciences scientific Shadman Nemati
17 shahrivar street, bank melli square, Amiralmomenin Hospital
Rasht Iran (Islamic Republic of) 4139638459 +98 13 3322 5242 drshadmannemati_ent@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) All patients with chronic otitis media with simple TM perforation and the age range of 18 to 65 years 18 years 65 years Both ABG > 40 db ossicular disorders Evidence of cholesteatoma Complete perforation without edge (at least 2 mm) TM Active otorrhea during recent a month Presence of large and thick plaques of tympanosclerosis in the edges of perforation underlying diseases such as diabetes, hypothyroidy, severe uremia, bleeding diseases, immunodeficiency diseases smoking Evidence in favor of Eustachian tube disorder, such as bilateral perforation, bilateral otorrhea, atelectatic ears, etc H72.0 Central perforation of tympanic membrane Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: , gelfoam is used in group A. Intervention group: Fat block is used in group B.In order to prepare fat blocks, about 0.5 to 1 cubic centimeter is removed from the same place of skin incision and from the fat under the skin, and it is pressed and dried by Fat Presser Intervention group: In group C, a combination of gelfoam and fat block pressed together is used. In this group, along with the piece of fat, the same amount of Gelfoam is placed in the Fat Presser and they are pressed and dried together.Then they are cut into blocks and small pieces of 2 x 3 mm by a surgical knife. Link success rate. Timepoint: before surgery and 3 months after surgery. Method of measurement: Pure tone audiometry at frequencies of 512, 1024, 2048 Hz is used to measure ABG, and tympanogram and the amount and location of its peak (types A, B, C) are used to check the health of the new tympanic membrane. (ABG rate ) air bone gap. Timepoint: before surgery and 3 months after surgery. Method of measurement: Pure tone audiometry at frequencies of 512, 1024, 2048 Hz is used to measure chatter, and tympanogram and the amount and location of its peak (types A, B, C) are used to check the health of the new tympanic membrane. Rasht university of medical science Approved 2022-06-01 کمیته اخلاق دانشگاه علوم پزشکی گیلان Amiralmomenin Hospital, 17 shahrivar street, bank melli square rasht Guilan Iran (Islamic Republic of)