Plastic Surgery, Postoperative Complications
Conditions
Brief summary
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.
Interventions
DEVICEPhotobiomodulation
The ELIXIR MD™ photobiomodulation (PBM) device is an FDA-cleared (510(k), GEX classification) medical-grade light therapy system. It delivers low-level, multi-wavelength light energy (blue 417nm, yellow 590-599nm, red 633nm) to targeted tissues. Three protocols are used: Detox (417nm blue light, pre-op), Cellular Repair (599nm yellow light, POD 0-7), and NeoXcell (633+590nm, POD 10 for light skin types Fitzpatrick I-III) or Roxium (417+590nm, POD 10 for darker skin types Fitzpatrick IV-V). Each session is 20 minutes. Manufactured by Yassen Wellness LLC, regulation 21 CFR 878.4810.
Sponsors
Elixir MD Inc
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged \> 18 years old 4. In good general health as evidenced by medical history 5. Patients presenting to the plastic surgery department at Cedars Sinai for facial or body plastic surgery 6. Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion criteria
1. Patient under 18 years of age 2. Blepharoplasty (the need for protective eyewear makes it impossible to include this surgery) 3. Antecedent of carcinoma, pregnancy, epilepsy, and thyroid conditions 4. Antecedent of photosensitive disease such as Lupus, porphyria, xeroderma pigmentosum 5. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FACE-Q and Body Metrics Questionnaire Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire) | Postoperative day 30 (POD30) | Mid-term patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) at postoperative day 30 |
| Blinded Edema Score on Standardized Photographs | POD1, 3, 7, 10, and 30 | Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30 |
| Percent Bruised Area (Ecchymosis) | POD1, 3, 7, 10, and 30 | Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator |
| Days from Surgery to Self-Reported Return to Usual Activities | POD10 and POD30 | Number of days from surgery date to self-reported resumption of usual daily activities, collected at POD10 and POD30 |
| Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs | Through postoperative day 30 (POD30) | Incidence and severity of device-related adverse events, serious adverse events, and unanticipated adverse device effects (UADEs) through postoperative day 30 |
| Visual Analog Scale (VAS) Pain Score | POD1, 2, 3, 5, 7, 10, and 30 | Patient-rated pain on a 0-10 Visual Analog Scale (VAS) after each session and at 1 month (0 = no pain, 10 = worst pain imaginable) |
Countries
United States
Outcome results
None listed