60
Participants
Start Date
October 30, 2025
Primary Completion Date
November 30, 2029
Study Completion Date
July 30, 2030
Photobiomodulation
The photobiomodulation device used in this study will be the ECCO Reability (Ecco Fibras, Campinas, SP, Brazil), which is approved for clinical use by the Brazilian Health Regulatory Agency (ANVISA) under registration number 80323310001. The equipment is also certified by INMETRO, ensuring adherence to nationally established safety and performance standards.
Simulation of Photobiomodulation
In the sham group, the photobiomodulation procedure will be simulated with the device turned off. To preserve blinding, the equipment will be positioned as in the active treatment and its operational sound will be reproduced during the simulation, ensuring that the intervention remains indistinguishable from the actual PBM application.
Standard treatment protocol
Participants in the control group will receive the standard medical protocol. No medication will be given preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered IV. Postoperative hospital care will include hydrocortisone 200 mg IV, tranexamic acid 250 mg IV, dipyrone 1 g IV, and cefazolin 1 g IV every 8 hours, plus ketorolac 10 mg sublingual as needed. At home, patients will take cefuroxime axetil 500 mg orally every 12 hours for 10 days, prednisolone 40 mg orally in the morning for 3 days, and dipyrone 1 g orally as needed. They will also apply a fibrinolysin and chloramphenicol ointment twice daily for 30 days and perform nasal irrigation with 0.9% sodium chloride six times daily for 60 days.
University of Nove de Julho
OTHER