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Enrolling By Invitation
NCT07311889
Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use
Conditions: Postoperative Pain, Postoperative Edema, Postoperative Ecchymosis, Surgical Wound Healing, Postsurgical Recovery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 300
Sponsor: Elixir MD Inc
Location: ELIXIR MD Inc Irvine California
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. 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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07311889). StuddyBuddy aggregates publicly available trial information.