Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

February 13, 2026 updated by: Elixir MD Inc

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • ELIXIR MD Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years or older undergoing elective plastic surgery procedures (facial or body) at participating plastic surgery practices. All participants receive perioperative care in which the ELIXIR MD™ photobiomodulation device may be used as part of standard clinical practice, at the discretion of the treating surgeon. The registry enrolls patients across a range of procedure types and skin phototypes and collects de-identified patient-reported and clinical recovery data during routine perioperative follow-up.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline (preoperative) through 10 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From surgery through 10 days postoperatively
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)
From surgery through 10 days postoperatively
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)
Up to 10 days postoperatively
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
Up to 10 days postoperatively
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
Up to 10 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elixir MD Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELIXIR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) generated in this observational registry, including patient-reported outcomes, procedure characteristics, and perioperative recovery assessments collected during routine clinical care. No direct identifiers will be shared.

IPD Sharing Time Frame

Beginning after publication of the primary study results and available upon reasonable request, with no predefined end date.

IPD Sharing Access Criteria

Access to de-identified individual participant data (IPD) and supporting study documents will be limited to qualified researchers with a legitimate scientific purpose. Researchers may request access by submitting a written proposal to the sponsor describing the research question, analysis plan, and intended use of the data.

Requests will be reviewed by the sponsor for scientific merit, feasibility, and compliance with ethical and privacy requirements. Approved researchers will be granted access only to de-identified participant-level data relevant to the approved proposal. No protected health information (PHI) will be shared.

Data access will be provided through secure data transfer or controlled access methods, subject to execution of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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