[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07311889":3,"trial-entities:NCT07311889":124,"trial-summary:NCT07311889":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":29,"primary_purpose":17,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":39,"secondary_outcomes":44,"sex":62,"minimum_age":63,"maximum_age":17,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":76,"locations":79,"central_contacts":89,"overall_officials":90,"references":91,"see_also_links":123},"NCT07311889","ELIXIR-001","Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use","Assessment of Patient Satisfaction and Healing Outcomes With the ELIXIR MD™ Device in the Perioperative Period of Plastic Surgery","ENROLLING_BY_INVITATION","2026-07-01","2025-12","2026-02-17","2026-01-19","Elixir MD Inc","INDUSTRY",false,"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.\n\nThe main questions this registry aims to answer are:\n\n1. How do patient-reported recovery outcomes, including pain, satisfaction, and perceived improvement, change over the postoperative period?\n2. How do clinician-assessed indicators of recovery, such as swelling and bruising, change over time following surgery?\n\nThis study does not include a randomized comparison group. Outcomes will be described longitudinally within participants based on data collected during routine care.\n\nParticipants will:\n\n1. Receive perioperative light therapy as part of standard clinical care, per their treating clinician\n2. Complete patient-reported outcome questionnaires at defined postoperative time points\n3. Undergo standardized clinical photography and routine clinical assessments as part of usual follow-up",null,[19,20,21,22,23],"Postoperative Pain","Postoperative Edema","Postoperative Ecchymosis","Surgical Wound Healing","Postsurgical Recovery",[25,26,27,28],"Photobiomodulation","Plastic Surgery","Postoperative Care","Patient-Reported Outcomes","OBSERVATIONAL",[],{"count":32,"type":33},300,"ESTIMATED",[35],{"type":36,"name":37,"description":38},"OTHER","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.",[40],{"measure":41,"description":42,"timeFrame":43},"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.\n\nMean satisfaction score (0-10)\n\n% of patients reporting high satisfaction (≥7)","From baseline (preoperative) through 10 days postoperatively",[45,49,52,56,59],{"measure":46,"description":47,"timeFrame":48},"Pain Intensity","Adapted from PROMIS Pain Intensity numeric rating scale\n\nPRS 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.\n\nUnit Mean pain score Mean change from baseline","From surgery through 10 days postoperatively",{"measure":50,"description":51,"timeFrame":48},"Global Rating of Change (Recovery)","Adapted from GROC (classic -5 to +5 format)\n\nGlobal 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.\n\nUnit Mean GROC score\n\n% reporting improvement (≥+2)",{"measure":53,"description":54,"timeFrame":55},"Swelling \u002F Tightness \u002F Bruising","Adapted from Common postoperative symptom severity NRS\n\nPatient-reported swelling severity assessed using a study-specific numeric rating scale adapted from commonly used postoperative symptom severity measures.\n\nUnit Mean swelling score (1-5) Change from baseline","Up to 10 days postoperatively",{"measure":57,"description":58,"timeFrame":55},"Scar Appearance & Symptoms","Adapted from Patient Scar Assessment Questionnaire (PSAQ - short form)\n\nScar appearance and symptoms assessed using items adapted from the Patient Scar Assessment Questionnaire (PSAQ), including appearance, symptoms, awareness, and satisfaction domains.\n\nUnit Mean domain scores (1-5)",{"measure":60,"description":61,"timeFrame":55},"Return to Normal Activities","Adapted from Standard postoperative time-to-event self-report\n\nTime to return to usual daily activities assessed by patient-reported number of days from surgery to perceived return to baseline activity.\n\nUnit Days","ALL","18 Years",true,{"inclusion":66,"exclusion":69,"raw_text":75},[67,68],"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.",[70,71,72,73,74],"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.","Inclusion Criteria:\n\n* 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.\n* Able to provide informed consent and complete brief patient-reported questionnaires.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Basal cell carcinoma, thyroid disorders, or malignant tumors.\n* History of photosensitive skin disease or photosensitivity.\n* Epilepsy or seizure disorders.\n* 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.",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"ELIXIR MD Inc","Irvine","California","92612","United States",{"lat":87,"lon":88},33.66946,-117.82311,[],[],[92,96,99,102,105,108,111,114,117,120],{"pmid":93,"type":94,"citation":95},"32503238","BACKGROUND","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\u002Fjcm9061724.",{"pmid":97,"type":94,"citation":98},"29356026","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\u002Flsm.22791. Online ahead of print.",{"pmid":100,"type":94,"citation":101},"32410200","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\u002Fs00266-020-01760-9. Epub 2020 May 14.",{"pmid":103,"type":94,"citation":104},"33332651","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\u002Fphpp.12645. Epub 2020 Dec 23.",{"pmid":106,"type":94,"citation":107},"31183484","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\u002Fc9pp00089e. Epub 2019 Jun 11.",{"pmid":109,"type":94,"citation":110},"27943458","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\u002Fphpp.12282.",{"pmid":112,"type":94,"citation":113},"28986000","Baek WY, Byun IH, Yun IS, Kim JY, Roh TS, Lew DH, Kim YS. The effect of light-emitting diode (590\u002F830 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\u002Fj.jcms.2017.08.027. Epub 2017 Sep 2.",{"pmid":115,"type":94,"citation":116},"36836932","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\u002Flife13020575.",{"pmid":118,"type":94,"citation":119},"38674067","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\u002Fijms25084483.",{"pmid":121,"type":94,"citation":122},"26681143","Kuffler DP. Photobiomodulation in promoting wound healing: a review. Regen Med. 2016 Jan;11(1):107-22. doi: 10.2217\u002Frme.15.82. Epub 2015 Dec 18.",[],{"nct_id":4,"conditions":125,"biomarkers":131},[126,127,128,129,130,23],"Ecchymosis following surgical procedure","Non-healing surgical wound","Plastic Surgery Procedure","Postoperative death","Post-Operative Pain",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]