Postoperative Ecchymosis, Postoperative Edema, Postoperative Pain, Postsurgical Recovery, Surgical Wound Healing
Conditions
Keywords
Photobiomodulation, Plastic Surgery, Postoperative Care, Patient-Reported Outcomes
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. 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
Interventions
OTHERPerioperative 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.
Sponsors
Elixir MD Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported satisfaction with postoperative recovery | From baseline (preoperative) through 10 days postoperatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | From surgery through 10 days postoperatively | Adapted from PROMIS Pain Intensity numeric rating scale PRS 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. Unit Mean pain score Mean change from baseline |
| Global Rating of Change (Recovery) | From surgery through 10 days postoperatively | Adapted from GROC (classic -5 to +5 format) Global 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. Unit Mean GROC score % reporting improvement (≥+2) |
| Swelling / Tightness / Bruising | Up to 10 days postoperatively | Adapted from Common postoperative symptom severity NRS Patient-reported swelling severity assessed using a study-specific numeric rating scale adapted from commonly used postoperative symptom severity measures. Unit Mean swelling score (1-5) Change from baseline |
| Scar Appearance & Symptoms | Up to 10 days postoperatively | Adapted from Patient Scar Assessment Questionnaire (PSAQ - short form) Scar appearance and symptoms assessed using items adapted from the Patient Scar Assessment Questionnaire (PSAQ), including appearance, symptoms, awareness, and satisfaction domains. Unit Mean domain scores (1-5) |
| Return to Normal Activities | Up to 10 days postoperatively | Adapted from Standard postoperative time-to-event self-report Time to return to usual daily activities assessed by patient-reported number of days from surgery to perceived return to baseline activity. Unit Days |
Countries
United States
Outcome results
None listed