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Postoperative PainNCT07311889

Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

An observational study of Postoperative Pain and Postoperative Edema, run by Elixir MD Inc at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Perioperative photobiomodulation light therapy
How many people
300 participants
Where
1 siteUnited States
Study dates
19 Jan 2026to 1 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • ELIXIR MD Inc

    Irvine, California, 92612

Other trials in United States

About this study

Official title: 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:

Read more
  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
Being tested
Perioperative photobiomodulation light therapy
Keywords
Photobiomodulation, Plastic Surgery, Postoperative Care, Patient-Reported Outcomes
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perioperative photobiomodulation light therapyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported satisfaction with postoperative recovery

    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)

    Measured: From baseline (preoperative) through 10 days postoperatively

Secondary outcomes (5)

  1. Pain Intensity

    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

    Measured: From surgery through 10 days postoperatively

  2. Global Rating of Change (Recovery)

    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)

    Measured: From surgery through 10 days postoperatively

  3. Swelling / Tightness / Bruising

    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

    Measured: Up to 10 days postoperatively

  4. Scar Appearance & Symptoms

    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)

    Measured: Up to 10 days postoperatively

  5. Return to Normal Activities

    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

    Measured: Up to 10 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2025
  2. Study start19 Jan 2026
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07311889
Sponsor's protocol ID
ELIXIR-001
Status last verified
Dec 2025
First submitted
16 Dec 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.

    PubMed 32503238

  • Jagdeo J, Austin E, Mamalis A, Wong C, Ho D, Siegel DM. Light-emitting diodes in dermatology: A systematic review of randomized controlled trials. Lasers Surg Med. 2018 Jan 22;50(6):613-28. doi: 10.1002/lsm.22791. Online ahead of print.

    PubMed 29356026

  • Karimi S, Sadeghi M, Amali A, Saedi B. Effect of Photobiomodulation on Ecchymosis after Rhinoplasty: A Randomized Single-Blind Controlled Trial. Aesthetic Plast Surg. 2020 Oct;44(5):1685-1691. doi: 10.1007/s00266-020-01760-9. Epub 2020 May 14.

    PubMed 32410200

  • Topaloglu N, Ozdemir M, Cevik ZBY. Comparative analysis of the light parameters of red and near-infrared diode lasers to induce photobiomodulation on fibroblasts and keratinocytes: An in vitro study. Photodermatol Photoimmunol Photomed. 2021 May;37(3):253-262. doi: 10.1111/phpp.12645. Epub 2020 Dec 23.

    PubMed 33332651

  • Serrage H , Heiskanen V , Palin WM , Cooper PR , Milward MR , Hadis M , Hamblin MR . Under the spotlight: mechanisms of photobiomodulation concentrating on blue and green light. Photochem Photobiol Sci. 2019 Aug 1;18(8):1877-1909. doi: 10.1039/c9pp00089e. Epub 2019 Jun 11.

    PubMed 31183484

  • Yadav A, Gupta A. Noninvasive red and near-infrared wavelength-induced photobiomodulation: promoting impaired cutaneous wound healing. Photodermatol Photoimmunol Photomed. 2017 Jan;33(1):4-13. doi: 10.1111/phpp.12282.

    PubMed 27943458

  • Baek WY, Byun IH, Yun IS, Kim JY, Roh TS, Lew DH, Kim YS. The effect of light-emitting diode (590/830 nm)-based low-level laser therapy on posttraumatic edema of facial bone fracture patients. J Craniomaxillofac Surg. 2017 Nov;45(11):1875-1877. doi: 10.1016/j.jcms.2017.08.027. Epub 2017 Sep 2.

    PubMed 28986000

  • Prado TP, Zanchetta FC, Barbieri B, Aparecido C, Melo Lima MH, Araujo EP. Photobiomodulation with Blue Light on Wound Healing: A Scoping Review. Life (Basel). 2023 Feb 18;13(2):575. doi: 10.3390/life13020575.

    PubMed 36836932

  • Hernandez-Bule ML, Naharro-Rodriguez J, Bacci S, Fernandez-Guarino M. Unlocking the Power of Light on the Skin: A Comprehensive Review on Photobiomodulation. Int J Mol Sci. 2024 Apr 19;25(8):4483. doi: 10.3390/ijms25084483.

    PubMed 38674067

  • Kuffler DP. Photobiomodulation in promoting wound healing: a review. Regen Med. 2016 Jan;11(1):107-22. doi: 10.2217/rme.15.82. Epub 2015 Dec 18.

    PubMed 26681143

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain and Postoperative Edema, run by Elixir MD Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported satisfaction with postoperative recovery (time frame: From baseline (preoperative) through 10 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07311889, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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