Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

Elixir MD Inc

Status: Not yet enrolling

Conditions: Postoperative Pain; Postsurgical Recovery; Postoperative Ecchymosis; Postoperative Edema; Surgical Wound Healing

Treatments: Other: Perioperative photobiomodulation light therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT07311889

ELIXIR-001

Details and patient eligibility

About

The goal of this observational registry study is to characterize postoperative recovery outcomes in adult patients receiving standard-of-care perioperative light therapy using an FDA-cleared photobiomodulation device as part of routine clinical practice. The study aims to describe changes in patient-reported and clinician-assessed recovery measures following elective surgical procedures.

The main questions this registry aims to answer are:

1. How do patient-reported recovery outcomes, including pain, satisfaction, and perceived improvement, change over the postoperative period?
2. How do clinician-assessed indicators of recovery, such as swelling and bruising, change over time following surgery?

This study does not include a randomized comparison group. Outcomes will be described longitudinally within participants based on data collected during routine care.

Participants will:

1. Receive perioperative light therapy as part of standard clinical care, per their treating clinician
2. Complete patient-reported outcome questionnaires at defined postoperative time points
3. Undergo standardized clinical photography and routine clinical assessments as part of usual follow-up

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older undergoing elective plastic surgery (facial or body procedures) at a participating plastic surgery practice where the ELIXIR MD™ device is used as part of standard perioperative care.
• Able to provide informed consent and complete brief patient-reported questionnaires.

Exclusion criteria

• Pregnancy.
• Basal cell carcinoma, thyroid disorders, or malignant tumors.
• History of photosensitive skin disease or photosensitivity.
• Epilepsy or seizure disorders.
• Recent use of photosensitizing medications, including isotretinoin within the past 6 months; tetracyclines or ciprofloxacin within the past 5 days; chlorpromazine within the past 8 days; methotrexate within the past 3 days; or amiodarone, per physician discretion.