Pre-surgery red and infrared light to reduce swelling after open rhinoplasty with osteotomies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, double-blind, sham-controlled trial will enroll 60 adults undergoing primary open rhinoplasty with piezo-assisted osteotomies and randomize them 1:1 to active or sham photobiomodulation (660 nm and 808 nm) one hour before surgery. Intervention and sham procedures use identical application steps to maintain masking, and assessors are blinded; surgical and perioperative care are standardized across participants. The primary outcome is periorbital edema on postoperative day 3 measured with a validated ordinal clinical scale and standardized photographs, and secondary outcomes include ecchymosis, pain, analgesic use, nasal tip skin thickness, and patient-reported aesthetic and functional outcomes. Participants will be followed for up to 12 months to capture longer-term functional and cosmetic results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Paulista de Otorrinolaringologia
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Cinthya CG Duran, PhD — University of Nove de Julho
• Study coordinator: Cinthya CG Duran, PhD
• Email: cinthya.cgduran@gmail.com
• Phone: 5511981628831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.