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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Periorbital Edema on postoperative day 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals 18-60 years of age;
- •ASA I or II; no comorbidities (no pre-existing diseases);
- •indication for rhinoplasty;
- •regardless of gender identity.
排除标准
- •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.
研究组 & 干预措施
Photobiomodulation Group
Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care.
干预措施: Photobiomodulation (Device)
Photobiomodulation Group
Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care.
干预措施: Standard treatment protocol (Procedure)
Simulation of Photobiomodulation Group
Participants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care.
干预措施: Simulation of Photobiomodulation (Other)
Simulation of Photobiomodulation Group
Participants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care.
干预措施: Standard treatment protocol (Procedure)
结局指标
主要结局
Periorbital Edema on postoperative day 3
时间窗: 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.
次要结局
- 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)
- Analgesic Consumption(3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively)
研究者
Cinthya Cosme Gutierrez Duran
PhD
University of Nove de Julho