Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use

Официальное название

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

Обзор

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

Вмешательства

• Другое 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.

Первичные конечные точки

• Patient-reported satisfaction with postoperative recovery [Срок оценки: From baseline (preoperative) through 10 days postoperatively]

Вторичные конечные точки (5)

• Pain Intensity [Срок оценки: From surgery through 10 days postoperatively]
• Global Rating of Change (Recovery) [Срок оценки: From surgery through 10 days postoperatively]
• Swelling / Tightness / Bruising [Срок оценки: Up to 10 days postoperatively]
• Scar Appearance & Symptoms [Срок оценки: Up to 10 days postoperatively]
• Return to Normal Activities [Срок оценки: Up to 10 days postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• ELIXIR MD Inc — Irvine

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07311889 · ELIXIR-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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