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

Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial

This will try a short preoperative session of red and infrared light in adults having primary open rhinoplasty with osteotomies to see if it reduces early periorbital swelling.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Nove de Julho (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07033039 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adults (18–60 years) with ASA I–II status scheduled for primary open rhinoplasty with piezo-assisted osteotomies and no significant comorbidities or contraindicated medications.

Not a fit: Patients undergoing closed or non‑piezo procedures, those on anticoagulants, anti‑inflammatories or corticosteroids, those with recent nasal fillers or isotretinoin use, or with significant comorbidities or intraoperative complications are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If effective, preoperative photobiomodulation could reduce early swelling and bruising after rhinoplasty, shortening recovery time and improving comfort and cosmetic outcomes.

How similar studies have performed: Small randomized and observational studies of low‑level laser or LED photobiomodulation in facial and postoperative settings have reported reductions in swelling and pain, but high‑quality sham‑controlled data specifically in rhinoplasty remain limited.

Eligibility criteria

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 this trial is running

São Paulo, São Paulo

• 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

Conditions Rhinoplasty; Edema; Photobiomodulation; Low-Level Laser Therapy; Postoperative; Inflammation