Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

NCT ID: NCT07311889

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Postoperative Pain Postoperative Edema Postoperative Ecchymosis Surgical Wound Healing Postsurgical Recovery

Keywords

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Photobiomodulation Plastic Surgery Postoperative Care Patient-Reported Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Perioperative photobiomodulation light therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elixir MD Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Clinical Research Manager

Role: CONTACT

Phone: 949-340-9911

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 32503238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29356026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32410200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33332651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31183484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27943458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28986000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36836932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38674067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26681143 (View on PubMed)

Other Identifiers

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ELIXIR-001

Identifier Type: -

Identifier Source: org_study_id