Perioperative Photobiomodulation With the ELIXIR MD System in Facial Plastic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Facial Bruising (Bruise Visibility Scale)
研究概览
简要总结
This study is testing whether a new light therapy schedule can reduce bruising after facial plastic surgery, compared with the light therapy schedule currently used in the investigator's practice.
Participants having elective facial plastic surgery (such as rhinoplasty, facelift and/or neck lift, blepharoplasty, or brow lift) at the study site may take part. All participants receive photobiomodulation (PBM), a non-contact light therapy already used in the practice as part of routine perioperative care. The study device, the ELIXIR MD system, delivers blue, yellow, red, and near-infrared light and is legally marketed in the United States under a U.S. Food and Drug Administration (FDA) 510(k) clearance, though its use in this study to evaluate reduction of postoperative bruising and swelling is not among its currently cleared uses.
Participants are randomly assigned (1:1) to one of two light therapy schedules: the schedule currently used in the practice, or a new multi-wavelength schedule being studied. Researchers do not know in advance which schedule reduces bruising more; that is the main question this study is designed to answer. The study is not placebo-controlled, because photobiomodulation is already part of routine care at the site; there is no untreated comparison group.
The main measurement is how visible facial bruising is about 7 days after surgery, based on standardized photographs graded by an assessor who does not know which treatment the participant received. The study also looks at facial swelling, pain, patient-reported recovery, and safety (including skin reactions and wound healing).
This is a small pilot study of about 40 participants at a single study site. It is designed to give an early estimate of whether the new schedule helps and to inform a future, larger study. It is not designed or statistically powered to prove that either schedule works.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Scheduled for elective facial plastic surgery at the study site: rhinoplasty, facelift and/or neck lift, blepharoplasty, brow lift, or a combination of these procedures.
- •Able and willing to attend the perioperative visits and standardized photography required by the protocol.
- •Able to read, understand, and provide written informed consent in English.
排除标准
- •Known photosensitivity disorder, or current use of a photosensitizing medication (for example, systemic isotretinoin, tetracyclines, amiodarone, methoxsalen, or systemic photodynamic agents), though this may be up to treating physician discretion.
- •Active facial infection or dermatitis at a treatment site.
- •History of keloid formation, or an uncontrolled pigmentary disorder (for example, active melasma or post-inflammatory hyperpigmentation under treatment).
- •Pregnancy or breastfeeding.
- •Therapeutic anticoagulation (for example, warfarin or a direct oral anticoagulant) or high-dose aspirin or nonsteroidal anti-inflammatory drug (NSAID) use that has not been discontinued preoperatively per the site's standard perioperative protocol.
- •Inability to provide independent informed consent, or reliance on a legally authorized representative. Adults who lack decisional capacity are not enrolled.
- •Concurrent enrollment in another interventional clinical study affecting facial healing or inflammation.
研究组 & 干预措施
Arm A: Current-Practice Photobiomodulation (PBM) Regimen
Perioperative photobiomodulation (PBM) via the ELIXIR MD system, using the regimen currently used in the investigator's practice. Blue 417 nanometers (nm) at 50 milliwatts per square centimeter (mW/cm2) preoperatively; yellow 590 nm (19.1 mW/cm2) at each postoperative session through postoperative day (POD) 7; red 633 nm + yellow 590 nm (64.1 mW/cm2 combined) at POD 10 (Cohort 1 schedule). Cohort 2 (isolated rhinoplasty/blepharoplasty) receives a reduced schedule per the protocol. Each session is 20 minutes, non-contact, at a working distance of 80-120 millimeters (mm).
干预措施: ELIXIR MD Photobiomodulation (PBM) System (Device)
Arm B: Investigational Multi-Wavelength Photobiomodulation (PBM) Regimen
Perioperative photobiomodulation (PBM) via the ELIXIR MD system, using the sponsor's proposed multi-wavelength regimen. Blue 417 nanometers (nm) at 50 milliwatts per square centimeter (mW/cm2) preoperatively (identical to Arm A); near-infrared 835 nm + yellow 590 nm (29.1 mW/cm2 combined) from the immediate postoperative session through postoperative day (POD) 2; near-infrared 835 nm + red 633 nm (55 mW/cm2 combined) at POD 7 and POD 10. Each session is 20 minutes, non-contact, at a working distance of 80-120 millimeters (mm). This regimen's benefit and risk profile are less well characterized than Arm A's.
干预措施: ELIXIR MD Photobiomodulation (PBM) System (Device)
结局指标
主要结局
Postoperative Facial Bruising (Bruise Visibility Scale)
时间窗: Postoperative Day 7 (±2 days)
Graded from standardized photographs (frontal and bilateral oblique views) using the Bruise Visibility Scale (BVS; Scafide et al., 2021), a 1-5 visual analogue scale developed and validated for in-person assessment of accidental bruises on the arms and legs. In this study the BVS is applied to standardized postoperative facial photographs, a context (face rather than limb, photograph rather than in-person, surgical rather than blunt-trauma etiology) in which it has not been formally validated; no claim of validation for this application is made. Grading is performed by a blinded assessor after all Postoperative Day 7 visits are complete.
次要结局
- Postoperative Facial Swelling (Investigator-Adapted Ordinal Scale)(Postoperative Day 7 (±2 days))
- Postoperative Pain Intensity (Numeric Rating Scale)(Baseline (preoperative), Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only))
- Number of Participants With Analgesic Use at Each Visit(Baseline (preoperative), Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only))
- Change From Baseline in Patient-Reported Swelling Score (ELIXIR MD Brief Recovery Instrument, Item 2)(Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only))
- Number of Participants With Adverse Events(From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended))
- Number of Participants With Treatment-Area Erythema(From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended))
- Number of Participants With Treatment-Area Pigmentary Change(From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended))
- Number of Participants With Wound Complications(From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended))
- Change From Baseline in Patient-Reported Bruising Score (ELIXIR MD Brief Recovery Instrument, Item 3)(Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only))
- Change From Baseline in Patient-Reported Overall Recovery Score (ELIXIR MD Brief Recovery Instrument, Item 4)(Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only))
- Change From Baseline in Patient-Reported Return to Normal Activities Score (ELIXIR MD Brief Recovery Instrument, Item 5)(Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only))