ELIXIR MDTM Satisfaction Clinical Trial

N/AActive Not RecruitingNCT07676643

Elixir MD Inc148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

148

Conditions

Postoperative Complications Plastic Surgery

Interventions

PhotobiomodulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in FACE-Q and Body Metrics Questionnaire Score

Patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) scores, measured before and after each session

Time frame: From baseline (POD0) to postoperative day 10 (POD10)

Secondary Outcomes

Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)

Mid-term patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) at postoperative day 30

Time frame: Postoperative day 30 (POD30)

Blinded Edema Score on Standardized Photographs

Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30

Time frame: POD1, 3, 7, 10, and 30

Percent Bruised Area (Ecchymosis)

Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator

Time frame: POD1, 3, 7, 10, and 30

Days from Surgery to Self-Reported Return to Usual Activities

Number of days from surgery date to self-reported resumption of usual daily activities, collected at POD10 and POD30

Time frame: POD10 and POD30

Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs

Incidence and severity of device-related adverse events, serious adverse events, and unanticipated adverse device effects (UADEs) through postoperative day 30

Time frame: Through postoperative day 30 (POD30)

Visual Analog Scale (VAS) Pain Score

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)

Time frame: POD1, 2, 3, 5, 7, 10, and 30