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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 11 wordsv4
  2. Study description shortened, about 67 wordsv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Start date changed from estimate of Oct 30, 2025 to Jan 30, 2026
    • Primary endpoints: 2 to 1
    • Study sites: 0 to 1
    • Study completion date: Jul 30, 2030 to Nov 30, 2030
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: 35 to 6
    • Study description expanded, about 33 words
    • Study title expanded, about 4 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07033039
Lead Sponsor University of Nove de Julho
Conditions
(from sponsor)		 Rhinoplasty, Edema
Related terms Edema, Inflammation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov