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IRCT20251118068031N1 IRCT 2025-12-25 Tehran University of Medical Sciences Evaluation of the effectiveness of platelet-rich fibrin on reducing complications after total thyroidectomy surgeries Evaluation of the effectiveness of platelet-rich fibrin on reducing complications after total thyroidectomy surgeries 2025-12-21 anticipated 44 Recruiting https://irct.ir/trial/87600 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will use block randomization at the individual level. A random sequence will be generated using a computer-generated list of random binary numbers in Microsoft Excel, with a fixed block size of four. In total, 11 blocks of four will be created, each containing 2 participants in the case group(assigned the number 1) and 2 participants in the control group(assigned the number 0). Eligible surgical patients will be assigned to these blocks according to their surgical order upon admission. The allocation sequence will be managed by a secretary who is not involved in the clinical evaluations and is aware of the group assignments. This secretary will be responsible for assigning participants based on the predetermined random list, Blinding description: To ensure blinding, outcome assessors, researchers, and patients will be kept unaware of group assignments(double-blind). Only the Platelet-Rich Fibrin(PRF) injection technician will be informed about the patient assignments. The PRF injection team will be independent from the surgical team. Consequently, the operating surgeon will have no knowledge of group allocations, preserving blinding integrity for the surgical team and other involved personnel. The PRF injection technician will administer PRF in the case group and inject normal saline using the same method and equipment as the PRF injection as a placebo in the control group. The technician performing the PRF injection cannot be blinded to the grouping due to the nature of the intervention. 3 Condition 1: Surgical scar formation site after total thyroidectomy. Condition 2: Postsurgical hematoma after total thyroidectomy. Intervention 1: Intervention group: Injection of Injectable Platelet-Rich Fibrin(i-PRF) during the surgery into the surgical bed prior to suturing, and placement of Concentrated Platelet-Rich Fibrin(C-PRF) in the surgical bed. Intervention 2: Control group: Standard surgical procedure without the use of Platelet-Rich Fibrin(PRF) (using only normal saline injection). 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 Permission must be obtained from the ethics committee and the funding institution before sharing this data.
public Maryam Namjoo Moghadam
Sa'adi street, Amir Alam Hospital
Tehran Iran (Islamic Republic of) 1145765111 9889338555371 m-namjoomoghadam@razi.tums.ac.ir Tehran University of Medical Sciences scientific Saeed Sohrabpour
Sa'adi Street, Amiralam hospital
Tehran Iran (Islamic Republic of) 1145765111 9889338555371 sohrab.saeed1364@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for total thyroidectomy over 18 years of age No history of neck surgery Normal preoperative calcium levels 18 years no limit Both Coagulation disorders Use of therapeutic-dose anticoagulant medications(except for prophylaxis) Known sensitivity to any of the components of PRP or fibrin History of radiotherapy or extensive surgery in the neck region Presence of active infection or advanced malignancy with metastasis L90.5 E89.810 Scar conditions and fibrosis of skin Postprocedural hemorrhage and hematoma of an endocrine system organ or structure following an endocrine system procedure Prevention Placebo Intervention group: Injection of Injectable Platelet-Rich Fibrin(i-PRF) during the surgery into the surgical bed prior to suturing, and placement of Concentrated Platelet-Rich Fibrin(C-PRF) in the surgical bed. Control group: Standard surgical procedure without the use of Platelet-Rich Fibrin(PRF) (using only normal saline injection). Postsurgical scar appearance following total thyroidectomy surgery. Timepoint: Immediately after surgery and 1,6 months after surgery. Method of measurement: The Patient and Observer Scar Assessment Scale , The Vancouver Scar Scale. Patient satisfaction with scar appearance following total thyroidectomy surgery. Timepoint: Immediately after surgery and 1,6 months after surgery. Method of measurement: Visual Analog Scale. Postoperative drainage duration. Timepoint: during recovery time. Method of measurement: Based on observation of the surgical site. Postoperative drainage volume. Timepoint: during recovery time. Method of measurement: Based on observation of the surgical site. Blood calcium level. Timepoint: Before surgery, 1,2 ,7 days after surgery and 1 month after surgery. Method of measurement: Free blood calcium level measured by lab. Duration of Postoperative Hospitalization. Timepoint: At discharge. Method of measurement: Based on hospitalization documents. Tehran University of Medical Sciences Approved 2025-10-20 Research Ethics Committees of Amir A'lam Hospital Complex Sa'adi street, Amir Alam Hospital Tehran Tehran Iran (Islamic Republic of)