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

ConditionsRhinoplastyEdema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Nove de Julho

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

individuals 18-60 years of age;

ASA I or II; no comorbidities (no pre-existing diseases);

indication for rhinoplasty;

regardless of gender identity.

Disqualifiers

use of anticoagulant,

anti-inflammatory, or corticosteroid medications;

indication for closed rhinoplasty;

procedures not performed using the Piezo device (Schuster SW Surgery II);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Photobiomodulation

    Device

    The photobiomodulation device used in this study will be the ECCO Reability (Ecco Fibras, Campinas, SP, Brazil), which is approved for clinical use by the Brazilian Health Regulatory Agency (ANVISA) under registration number 80323310001. The equipment is also certified by INMETRO, ensuring adherence to nationally established safety and performance standards.

  • Simulation of Photobiomodulation

    Other intervention

    In the sham group, the photobiomodulation procedure will be simulated with the device turned off. To preserve blinding, the equipment will be positioned as in the active treatment and its operational sound will be reproduced during the simulation, ensuring that the intervention remains indistinguishable from the actual PBM application.

  • Standard treatment protocol

    Procedure/Surgery

    All participants will undergo primary open rhinoplasty performed using piezo-assisted osteotomies, following standardized surgical protocols. Subperiosteal dissection will be carried out along the lateral nasal walls, with supraperiosteal dissection in the medial region of the bony nasal dorsum. The configuration of osteotomies will be selected according to individual anatomical and surgical requirements. All procedures will be performed by experienced otolaryngologists. All participants will also receive standardized perioperative medical care, identical in both groups. No medication will be administered preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered intravenously. Postoperative in-hospital care will include hydrocortisone 200 mg IV, tranexamic acid 250 mg IV, dipyrone 1 g IV, and cefazolin 1 g IV every 8 hours, with ketorolac 10 mg sublingual as needed. After discharge, patients will receive cefuroxime axetil 500 mg orally every 12

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Photobiomodulation GroupExperimental treatment 2 interventions
Group B: Simulation of Photobiomodulation GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Periorbital Edema on postoperative day 3

Periorbital edema on postoperative day 3 will be assessed using the Hoffmann Clinical Ordinal Scale for Periorbital Edema (score range 0 to 4), based on the extent of eyelid involvement. In this scale, higher scores indicate more severe edema and therefore a worse outcome. Assessments will be performed by a blinded and calibrated evaluator. Standardized photographic documentation will be obtained and analyzed using ImageJ software as a complementary objective measurement.

Time frame
Postoperative day 3

Secondary outcomes

1

Periorbital Edema Time Course

Periorbital edema assessed using the Hoffmann clinical scale (0-4), based on eyelid involvement, evaluated by a blinded and calibrated assessor, with standardized photographic documentation and complementary ImageJ analysis.

Time frame
7, 30, 60, and 90 days; 6 and 12 months postoperatively
2

Periorbital Ecchymosis

Periorbital ecchymosis assessed using the Hoffmann clinical ordinal scale (0-4), based on the extent and intensity of periorbital discoloration, evaluated by a trained assessor blinded to group allocation.

Time frame
3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
3

Nasal Tip Skin Thickness

Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.

Time frame
Preoperative baseline; 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
4

Postoperative Pain (VAS)

Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.

Time frame
3 and 7 days postoperatively

Other outcomes

Sponsors and contacts

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University of Nove de Julho

Lead sponsor

Source ClinicalTrials.gov
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