Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-13; most recent amendment 2026-03-19.
Status change: Not Yet Recruiting → Recruiting 2026-02-07
Trial Details
NCT Number NCT07033039
Lead Sponsor University of Nove de Julho
Conditions Rhinoplasty, Edema
Enrollment 60 participants
Start Date 2026-01-30
Primary Completion 2029-11-30 (estimated)
Study Completion 2030-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-24