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

RecruitingNAAges 18 Years - 60 YearsAllUniversity of Nove de Julho
NCT07033039 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion criteria: * individuals 18-60 years of age; * ASA I or II; no comorbidities (no pre-existing diseases); * indication for rhinoplasty; * regardless of gender identity. Exclusion criteria: * use of anticoagulant, * anti-inflammatory, or corticosteroid medications; * indication for closed rhinoplasty; * procedures not performed using the Piezo device (Schuster SW Surgery II); * intraoperative complications (e.g., haemorrhage or technical difficulties); * prior nasal filler with hyaluronic acid; * use of vitamin A derivatives (oral isotretinoin or topical retinoic acid) within 30 days before surgery; * or known allergy to any mandatory intra- or postoperative medication.
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What it tests

  • Photobiomodulation
  • Simulation of Photobiomodulation
  • Standard treatment protocol
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Where

1 site
Hospital Paulista de Otorrinolaringologia
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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