Efficacy and Safety of the Photobiomodulation Device ELIXIR in Postoperative Plastic Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change in FACE-Q and Body Metrics Questionnaire Score
研究概览
简要总结
This study aims to assess patient satisfaction from the use of the ELIXIR MD™ photobiomodulation (PBM) device in the perioperative period of facial and body reconstructive surgery at Cedars-Sinai Medical Center. The ELIXIR MD™ device is FDA-cleared (510(k), product code GEX) and delivers low-level, multi-wavelength light energy to targeted tissues to promote cellular repair, reduce inflammation, and enhance patient recovery. Participants undergoing elective facial or body plastic surgery will be randomized 1:1 to receive either active ELIXIR MD™ PBM treatment or sham (placebo) treatment. A total of 8 treatment sessions are scheduled: one preoperative session and sessions on POD 0, 1, 2, 3, 5, 7, and 10, each lasting 20 minutes. A final follow-up visit occurs at POD 30. Patient-reported outcomes (FACE-Q and Body Metrics Questionnaire), blinded edema and ecchymosis assessments via standardized photography, pain scores (VAS), and time to return to usual activities will be evaluated. The study enrolls 148 participants (74 per arm) with equal representation of facial and body surgery patients.
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
- Double (Participant, 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
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged > 18 years old
- •In good general health as evidenced by medical history
- •Patients presenting to the plastic surgery department at Cedars Sinai for facial or body plastic surgery
- •Agreement to adhere to Lifestyle Considerations throughout study duration
排除标准
- •Patient under 18 years of age
- •Blepharoplasty (the need for protective eyewear makes it impossible to include this surgery)
- •Antecedent of carcinoma, pregnancy, epilepsy, and thyroid conditions
- •Antecedent of photosensitive disease such as Lupus, porphyria, xeroderma pigmentosum
- •Patient taking medications that cause photosensitivity, including: Chlorpromazine (unless not taken within last 8 days), Griseofulvin (unless not taken within last 5 days), Isotretinoin (unless not taken within last 6 months), Tetracyclines (unless not taken within last 5 days), Methotrexate (unless not taken within last 3 days), Amiodarone (at physician's discretion), Hydroquinone (unless not taken within last 2 weeks)
结局指标
主要结局
Change in FACE-Q and Body Metrics Questionnaire Score
时间窗: From baseline (POD0) to postoperative day 10 (POD10)
Patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) scores, measured before and after each session
次要结局
- Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)(Postoperative day 30 (POD30))
- Blinded Edema Score on Standardized Photographs(POD1, 3, 7, 10, and 30)
- Percent Bruised Area (Ecchymosis)(POD1, 3, 7, 10, and 30)
- Days from Surgery to Self-Reported Return to Usual Activities(POD10 and POD30)
- Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs(Through postoperative day 30 (POD30))
- Visual Analog Scale (VAS) Pain Score(POD1, 2, 3, 5, 7, 10, and 30)