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

NCT07033039 | Recruiting

• 1 other identifier: 7.503.097
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edema; Rhinoplasty

Keywords

Photobiomodulation; Low-Level Laser Therapy; Postoperative; Inflammation

Outcome Measures

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.

  Postoperative day 3

Secondary Outcomes (6)

• Periorbital Edema Time Course

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

• Periorbital Ecchymosis

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

• Nasal Tip Skin Thickness

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

• Postoperative Pain (VAS)

  3 and 7 days postoperatively

• Patient-Reported Functional and Aesthetic Outcomes (SCHNOS)

  Preoperative baseline; 30 and 90 days; 6 and 12 months postoperatively

Study Arms (2)

Photobiomodulation Group

EXPERIMENTAL

Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care.

Device: Photobiomodulation; Procedure: Standard treatment protocol

Simulation of Photobiomodulation Group

SHAM COMPARATOR

Participants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care.

Other: Simulation of Photobiomodulation; Procedure: Standard treatment protocol

Interventions

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.

Photobiomodulation Group

Simulation of Photobiomodulation OTHER

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.

Simulation of Photobiomodulation Group

Standard treatment protocol PROCEDURE

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

Photobiomodulation Group; Simulation of Photobiomodulation Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• individuals 18-60 years of age;
• ASA I or II; no comorbidities (no pre-existing diseases);
• indication for rhinoplasty;
• regardless of gender identity.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Hospital Paulista de Otorrinolaringologia

São Paulo, São Paulo, 02404001, Brazil

RECRUITING

MeSH Terms

Conditions

Edema; Inflammation

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Cinthya CG Duran, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinthya CG Duran, PhD

CONTACT

5511981628831; cinthya.cgduran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the researcher responsible for administering the treatments, who will open the randomization envelopes, will be aware of the participants' group allocation. Group identification will be disclosed only after statistical analysis, ensuring blinding of all other individuals involved in the study. The researcher responsible for data collection, including the assessment of edema and all secondary outcomes, as well as the statistician, will remain blinded to group assignments. Additionally, participants will not be informed of the intervention received. To ensure blinding, the device will remain turned off for the control group, and its use will be simulated by the healthcare professional responsible for administering the photobiomodulation (PBM). The device sound will also be reproduced to simulate activation, ensuring that participants are unaware of differences between interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: randomized, controlled, single centre, double-blind clinical trial

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: upon reasonable request.
• Access Criteria: corresponding author upon reasonable request

Locations

BR (1)