Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Nove de Julho

About this trial

This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Sixty participants will be randomly assigned to receive active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3 measured using a validated ordinal clinical scale with standardized photographic documentation. Secondary outcomes include ecchymosis, postoperative pain, analgesic consumption, nasal tip skin thickness, and patient-reported functional and aesthetic outcomes. Participants will be followed for up to 12 months after surgery.

Eligibility criteria

Qualifiers

individuals 18-60 years of age;

ASA I or II; no comorbidities (no pre-existing diseases);

indication for rhinoplasty;

regardless of gender identity.

Disqualifiers

use of anticoagulant,

anti-inflammatory, or corticosteroid medications;

indication for closed rhinoplasty;

procedures not performed using the Piezo device (Schuster SW Surgery II);

Trial design

Treatments tested in this trial

  • Photobiomodulation
  • Simulation of Photobiomodulation
  • Standard treatment protocol

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1
Hospital Paulista de Otorrinolaringologia02404001, São PauloSão Paulo, Brazil

Sponsors and collaborators

University of Nove de Julho

Lead sponsor