Evaluation of Preventive Photobiomodulation in Postoperative Rhinoplasty Edema

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 30, 2025

Primary Completion Date

November 30, 2029

Study Completion Date

July 30, 2030

Conditions
RhinoplastyEdema
Interventions
DEVICE

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.

OTHER

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.

PROCEDURE

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.

All Listed Sponsors
lead

University of Nove de Julho

OTHER

NCT07033039 - Evaluation of Preventive Photobiomodulation in Postoperative Rhinoplasty Edema | Biotech Hunter | Biotech Hunter