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OpenTrials
Enrolling by Invitation

NCT Number: NCT07311889

Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Ecchymosis Postoperative Edema Postsurgical Recovery Signs and Symptoms Surgical Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ELIXIR MD Inc

Irvine, California, 92612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perioperative photobiomodulation light therapy

Other

Participants may receive perioperative light therapy as part of routine clinical care at the discretion of their treating clinician. The study does not assign, modify, or mandate the use of light therapy. Data are collected observationally to describe recovery outcomes associated with standard clinical practice.

Primary outcomes

  1. Patient-reported satisfaction with postoperative recovery

    Time frame: From baseline (preoperative) through 10 days postoperatively

    Patient-reported satisfaction with postoperative recovery assessed using a study-specific Global Satisfaction item adapted from Global Rating of Change (GROC) methodology. Responses are collected on a numeric Likert scale during routine postoperative follow-up and analyzed descriptively.

    Mean satisfaction score (0-10)

    % of patients reporting high satisfaction (≥7)

Secondary outcomes

  1. Pain Intensity

    Time frame: From surgery through 10 days postoperatively

    Adapted from PROMIS Pain Intensity numeric rating scale

    PRS Description Pain intensity assessed using a numeric rating scale adapted from the PROMIS Pain Intensity measure (0-10). Scores are collected pre- and postoperatively and summarized descriptively as change from baseline.

    Unit Mean pain score Mean change from baseline

  2. Global Rating of Change (Recovery)

    Time frame: From surgery through 10 days postoperatively

    Adapted from GROC (classic -5 to +5 format)

    Global recovery assessed using a Global Rating of Change (GROC) scale ranging from -5 (much worse) to +5 (very much better), capturing patient-perceived change in pain or healing compared to baseline.

    Unit Mean GROC score

    % reporting improvement (≥+2)

  3. Swelling / Tightness / Bruising

    Time frame: Up to 10 days postoperatively

    Adapted from Common postoperative symptom severity NRS

    Patient-reported swelling severity assessed using a study-specific numeric rating scale adapted from commonly used postoperative symptom severity measures.

    Unit Mean swelling score (1-5) Change from baseline

  4. Scar Appearance & Symptoms

    Time frame: Up to 10 days postoperatively

    Adapted from Patient Scar Assessment Questionnaire (PSAQ - short form)

    Scar appearance and symptoms assessed using items adapted from the Patient Scar Assessment Questionnaire (PSAQ), including appearance, symptoms, awareness, and satisfaction domains.

    Unit Mean domain scores (1-5)

  5. Return to Normal Activities

    Time frame: Up to 10 days postoperatively

    Adapted from Standard postoperative time-to-event self-report

    Time to return to usual daily activities assessed by patient-reported number of days from surgery to perceived return to baseline activity.

    Unit Days

Sponsors and collaborators

Lead sponsor

Elixir MD Inc

Industry

Registry information

Official study title

Assessment of Patient Satisfaction and Healing Outcomes With the ELIXIR MD™ Device in the Perioperative Period of Plastic Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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