Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

NCT07311889 | Enrolling By Invitation

• 1 other identifier: ELIXIR-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.How do patient-reported recovery outcomes, including pain, satisfaction, and perceived improvement, change over the postoperative period?
2. 2.How do clinician-assessed indicators of recovery, such as swelling and bruising, change over time following surgery?
3. 3.Receive perioperative light therapy as part of standard clinical care, per their treating clinician
4. 4.Complete patient-reported outcome questionnaires at defined postoperative time points
5. 5.Undergo standardized clinical photography and routine clinical assessments as part of usual follow-up

Conditions

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

Keywords

Photobiomodulation; Plastic Surgery; Postoperative Care; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (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)

  From baseline (preoperative) through 10 days postoperatively

Secondary Outcomes (5)

• Pain Intensity

  From surgery through 10 days postoperatively

• Global Rating of Change (Recovery)

  From surgery through 10 days postoperatively

• Swelling / Tightness / Bruising

  Up to 10 days postoperatively

• Scar Appearance & Symptoms

  Up to 10 days postoperatively

• Return to Normal Activities

  Up to 10 days postoperatively

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elixir MD Inc: lead

Study Sites (1)

ELIXIR MD Inc

Irvine, California, 92612, United States

Location

Related Publications (10)

• 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.

  PMID: 32503238 BACKGROUND

• 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.

  PMID: 29356026 BACKGROUND

• 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.

  PMID: 32410200 BACKGROUND

• 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.

  PMID: 33332651 BACKGROUND

• 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.

  PMID: 31183484 BACKGROUND

• 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.

  PMID: 27943458 BACKGROUND

• 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.

  PMID: 28986000 BACKGROUND

• 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.

  PMID: 36836932 BACKGROUND

• 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.

  PMID: 38674067 BACKGROUND

• 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.

  PMID: 26681143 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: January 19, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning after publication of the primary study results and available upon reasonable request, with no predefined end date.
• 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.

Locations

US (1)