An interventional study of Photobiomodulation and Simulation of Photobiomodulation in Rhinoplasty and Edema, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Prevention
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.
This is a single-centre, randomized, double-blind, sham-controlled clinical trial designed to investigate the effectiveness of preoperative photobiomodulation (PBM) using red (660 nm) and infrared (808 nm) light-emitting diodes in patients undergoing primary open rhinoplasty with piezo-assisted osteotomies. The study hypothesis is that prophylactic PBM applied one hour before surgery can modulate the early inflammatory response and reduce the intensity of postoperative periorbital edema.
Participants will be randomly allocated in a 1:1 ratio to active PBM or sham PBM. Allocation concealment will be ensured using a computer-generated randomization sequence and sealed assignment procedures. Both participants and outcome assessors will be blinded to group allocation. The intervention will be delivered preoperatively by trained personnel following a standardized operating protocol, with predefined anatomical application points and device parameter verification before each session. The sham procedure will follow identical steps, with the device inactive, in order to preserve masking.
All participants will undergo standardized surgical technique and perioperative care according to institutional protocols. Concomitant medications and perioperative management will be recorded to allow assessment of potential confounding effects.
The primary endpoint is assessed early in the postoperative period using a validated ordinal clinical scale applied by a calibrated blinded assessor, with standardized photographic documentation obtained under controlled conditions. Digital image analysis will be used as a complementary objective method to support clinical grading. Additional postoperative clinical and patient-reported measures are collected longitudinally to characterize recovery trajectory and treatment response.
Follow-up visits are scheduled at predefined postoperative time points extending to 12 months. Outcome assessors are trained and calibrated prior to study initiation to ensure inter-rater consistency. Data collection follows standardized case report forms and predefined operational definitions.
Statistical analysis will follow a modified intention-to-treat approach including all randomized participants with at least one postoperative assessment. The primary comparison between groups will use nonparametric methods appropriate for ordinal outcomes. Secondary analyses will be conducted according to data distribution and measurement scale. A two-sided significance level of 0.05 will be adopted. No interim analyses are planned.
Safety monitoring will be conducted throughout the study period, and any adverse events will be documented and reported in accordance with ethical and regulatory requirements.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 401 interventional studies indexed under Edema.
Browse Edema studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care.
Device: Photobiomodulation · Procedure: Standard treatment protocol
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
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.
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.
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
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
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
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
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
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
Patient-Reported Functional and Aesthetic Outcomes (SCHNOS)
Functional and aesthetic outcomes assessed using the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS), validated for Brazilian Portuguese.
Time frame: Preoperative baseline; 30 and 90 days; 6 and 12 months postoperatively
Analgesic Consumption
Total amount of analgesic medication ingested by each participant, recorded as an indirect indicator of postoperative pain control and functional recovery.
Time frame: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Plan to share: Yes — The datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request.
Time frame: upon reasonable request.
Access criteria: corresponding author upon reasonable request
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