Evaluation of Preventive Photobiomodulation in Postoperative Rhinoplasty Edema

NCT ID: NCT07033039

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2030-07-30

Brief Summary

This randomized, double-blind clinical trial aims to evaluate the efficacy of preoperative photobiomodulation (PBM) in reducing periorbital edema following rhinoplasty. Sixty patients will be randomly assigned to a PBM or control group. The PBM group will receive low-level laser therapy preoperatively at specific facial sites using a red (660 nm) and infrared (808 nm) laser cluster. Edema will be assessed via standardized scales and ImageJ software analysis. Secondary variables will include ecchymosis, pain sensitivity, skin thickness, and analgesic medication count. Additionally, a standardized and validated questionnaire for the Portuguese language, SCHNOS, will be used to evaluate aesthetic and functional outcomes in patients undergoing rhinoplasty. Assessments will be conducted during postoperative follow-up visits scheduled for days 3, 7, 30, 60, and 90, as well as at 6 and 12 months. Adverse effects will be recorded and reported. Statistical analysis will apply ANOVA, Friedman, and chi-square tests, with significance set at p < 0.05.

Detailed Description

Edema and ecchymosis are frequent postoperative manifestations of rhinoplasty, influenced by various factors such as the surgical technique used, pre and postoperative care, and the individual characteristics of patients. The prevention or early reduction of these conditions can have a significant impact on recovery, increasing patient satisfaction and accelerating the return to daily activities. Photobiomodulation (PBM) is recognized for its ability to reduce pain, modulate inflammation, and optimize tissue repair. Although studies have demonstrated the effectiveness of PBM in various clinical scenarios, such as wound treatment and postoperative pain management, its application in the specific context of rhinoplasty postoperative recovery remains underexplored. The objective of this study is to evaluate the effectiveness of PBM in reducing periorbital edema in patients undergoing rhinoplasty. For this purpose, 60 patients will be randomly divided into two groups: Control Group (n = 30) - patients will receive conventional treatment with a sham PBM application, and PBM Group (n = 30) - patients will receive conventional treatment and PBM application preoperatively at three cluster application sites, corresponding to the dorsal region and the frontal processes of the maxilla (right and left).. The treatment will be performed using a cluster with 3 red laser emitters (660 nm, 150 mW each) and 3 infrared laser emitters (808 nm, 150 mW each), applying 12 J per point (per laser) for 80 seconds. Edema will be assessed using the Hoffman visual scale and photographic records processed with the ImageJ software. Secondary variables will include ecchymosis, pain sensitivity, skin thickness, and analgesic medication count. Additionally, a standardized and validated questionnaire for the Portuguese language, SCHNOS, will be used to evaluate aesthetic and functional outcomes in patients undergoing rhinoplasty. Assessments will be conducted during postoperative follow-up visits scheduled for days 3, 7, 30, 60, and 90, as well as at 6 and 12 months. Adverse effects will be recorded and reported. Statistical analyses will be conducted using GraphPad Prism 5, with a significance level of p < 0.05. Normality will be assessed using the Shapiro-Wilk test. Normally distributed data will be presented as mean ± SD and analyzed using repeated measures ANOVA, while non-normal data will be expressed as median and IQR and analyzed using the Friedman test. The paired t-test will be used for ImageJ photo analysis, and the chi-square test or Fisher's exact test for categorical SCHNOS data.

Conditions

Rhinoplasty; Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Photobiomodulation Group

Photobiomodulation treatment will be administered by a trained healthcare professional one hour before surgery. The PBM will be applied directly to the patient's nasal region at three cluster application sites: the nasal dorsum and the frontal processes of the maxilla (right and left). The procedure will use a cluster comprising three red laser emitters (660 nm, 150 mW each) and three infrared laser emitters (808 nm, 150 mW each), delivering 12 J per point (per laser) over 80 seconds.

Group Type: EXPERIMENTAL

Simulation of Photobiomodulation

Intervention Type: 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.

Standard treatment protocol

Intervention Type: PROCEDURE

Participants in the control group will receive the standard medical protocol. No medication will be given preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered IV. Postoperative 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, plus ketorolac 10 mg sublingual as needed. At home, patients will take cefuroxime axetil 500 mg orally every 12 hours for 10 days, prednisolone 40 mg orally in the morning for 3 days, and dipyrone 1 g orally as needed. They will also apply a fibrinolysin and chloramphenicol ointment twice daily for 30 days and perform nasal irrigation with 0.9% sodium chloride six times daily for 60 days.

Simulation of Photobiomodulation Group

The Sham group will receive a simulated photobiomodulation (PBM) procedure one hour before undergoing rhinoplasty. To ensure the integrity of the blinding process, the PBM device will remain turned off during the simulation. Nonetheless, the equipment will be positioned and handled in the same manner as in the active treatment group. The device's characteristic sound will also be played to mimic real activation, making the procedure indistinguishable to the participants. This strategy aims to preserve the double-blind design of the study by ensuring that neither the patients nor the outcome assessors are aware of the group allocation.

Group Type: SHAM_COMPARATOR

Photobiomodulation

Intervention Type: 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.

Standard treatment protocol

Intervention Type: PROCEDURE

Participants in the control group will receive the standard medical protocol. No medication will be given preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered IV. Postoperative 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, plus ketorolac 10 mg sublingual as needed. At home, patients will take cefuroxime axetil 500 mg orally every 12 hours for 10 days, prednisolone 40 mg orally in the morning for 3 days, and dipyrone 1 g orally as needed. They will also apply a fibrinolysin and chloramphenicol ointment twice daily for 30 days and perform nasal irrigation with 0.9% sodium chloride six times daily for 60 days.

Interventions

Photobiomodulation

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.

Intervention Type: DEVICE

Simulation of Photobiomodulation

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.

Intervention Type: OTHER

Standard treatment protocol

Participants in the control group will receive the standard medical protocol. No medication will be given preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered IV. Postoperative 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, plus ketorolac 10 mg sublingual as needed. At home, patients will take cefuroxime axetil 500 mg orally every 12 hours for 10 days, prednisolone 40 mg orally in the morning for 3 days, and dipyrone 1 g orally as needed. They will also apply a fibrinolysin and chloramphenicol ointment twice daily for 30 days and perform nasal irrigation with 0.9% sodium chloride six times daily for 60 days.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

ASA physical status I or II

No comorbidities or pre-existing medical conditions

Scheduled for primary rhinoplasty -

Exclusion Criteria

Use of anticoagulant, anti-inflammatory, or corticosteroid medications

Indications for secondary or revision rhinoplasty

Indications for closed rhinoplasty

Surgical procedures performed using instruments other than a 3 mm curved angled osteotome with a guide for osteotomies

The occurrence of intraoperative complications, such as hemorrhage or technical difficulties

History of previous nasal filler procedures with hyaluronic acid

Use of vitamin A derivatives (e.g., oral isotretinoin or topical retinoic acid) within 30 days before surgery

Known allergy to any medications listed as mandatory for intraoperative or postoperative care

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Cinthya Cosme Gutierrez Duran

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cinthya CG Duran, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Central Contacts

Cinthya CG Duran, PhD

Role: CONTACT

cinthya.cgduran@gmail.com

11981628831

Other Identifiers

7.503.097

Identifier Type: -

Identifier Source: org_study_id