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IRCT20240128060826N1 IRCT 2024-02-13 Esfahan University of Medical Sciences Investigating the effect of using hydroxyapatite mesh on the occurrence of fistula in patients undergoing primary palatoplasty by the Sommerlad intravelar veloplasty method Investigating the effect of using hydroxyapatite mesh on the occurrence of fistula in patients undergoing primary palatoplasty by the Sommerlad intravelar veloplasty method 2024-02-20 anticipated 64 Complete https://irct.ir/trial/75324 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This stage will be Randomized Block Design. At this stage, patients will be divided into 2 blocks (32 blocks of 2). Then they are sorted according to the national code (the larger national code of the first row of the block and the smaller national code of the second row of the block). After that, we refer to the table of random numbers for each block. If the selected number was from 0 to 4, the patient in the first row will join group A and the patient in the second row will join group B. If the selected number was from 5 to 9, the patient in the first row will join group B and the patient in the second row will join group A. A blinded colleague determines that each of groups A and B will be the intervention group and the control group, Blinding description: The patient and the person analyzing the data are not aware of the type of surgery, and the sealed envelope containing the selection of group A and B as stated in the randomization section is presented to the surgeon in the operating room. N/A Cleft palate. Intervention 1: Intervention group: In the patients of the intervention group, in addition to the routine care and surgical procedures that will be performed, a hydroxyapatite mesh (manufactured by Hamsan Baft Adelie, Iran) will be placed in the palate. Intervention 2: Control group: In the patients of the control group, routine care and Sommerled surgical procedure will be performed, without using hydroxyapatite mesh. No - There is not a plan to make this available Justification or reason for not sharing IPD is Information is kept confidential.
public Hossein Abdali
Al-zahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 abdali@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hossein Abdali
Al-zahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 abdali@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Written informed consent from the patient's legal guardian to participate in the study Definitive diagnosis of cleft palate Surgery performed by a common surgeon Performing primary palatoplasty surgery using the intravelar veloplasty method and using a microscope no limit 3 years Both Presence of surgical site infections Unwillingness of the patient's guardian Q35 Cleft palate Treatment - Surgery Treatment - Surgery Intervention group: In the patients of the intervention group, in addition to the routine care and surgical procedures that will be performed, a hydroxyapatite mesh (manufactured by Hamsan Baft Adelie, Iran) will be placed in the palate. Control group: In the patients of the control group, routine care and Sommerled surgical procedure will be performed, without using hydroxyapatite mesh. Occurrence of fistula. Timepoint: 3 and 6 months after surgery. Method of measurement: Physical examination. Esfahan University of Medical Sciences Approved 2024-01-13 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Vice Chancellor for Research and Technology, Building No. 4, Hezar Jerib St., Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)