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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое 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.
• Процедура Standard treatment protocol
  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 a

Первичные конечные точки

• Periorbital Edema on postoperative day 3 [Срок оценки: Postoperative day 3]

Вторичные конечные точки (6)

• Periorbital Edema Time Course [Срок оценки: 7, 30, 60, and 90 days; 6 and 12 months postoperatively]
• Periorbital Ecchymosis [Срок оценки: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively]
• Nasal Tip Skin Thickness [Срок оценки: Preoperative baseline; 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively]
• Postoperative Pain (VAS) [Срок оценки: 3 and 7 days postoperatively]
• Patient-Reported Functional and Aesthetic Outcomes (SCHNOS) [Срок оценки: Preoperative baseline; 30 and 90 days; 6 and 12 months postoperatively]
• Analgesic Consumption [Срок оценки: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Hospital Paulista de Otorrinolaringologia — São Paulo

Публикации

• Azevedo MA, Dolci ELL, Maciel MLFL, Coelho MS, Kitamura RH, Quedas A, Bussadori SK, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Duran CCG. Effects of photobiomodulation with red and infrared low-level laser diodes in individuals undergoing rhinoplasty at a single centre in Sao Paulo, Brazil: protocol for a randomised, double-blind, controlled clinical trial. BMJ Open. 2026 Apr 27;16(4):e112 PMID 42044952

Идентификаторы

NCT: NCT07033039 · 7.503.097

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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