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NCT07846631
Perioperative Photobiomodulation in Facial Plastic Surgery
Conditions: Postoperative Facial Ecchymosis, Postoperative Facial Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Elixir MD Inc
Location: Dallas Plastic Surgery Institute Dallas Texas
Summary
This study is testing whether a new light therapy schedule can reduce bruising after facial plastic surgery, compared with the light therapy schedule currently used in the investigator's practice.
Participants having elective facial plastic surgery (such as rhinoplasty, facelift and/or neck lift, blepharoplasty, or brow lift) at the study site may take part. All participants receive photobiomodulation (PBM), a non-contact light therapy already used in the practice as part of routine perioperative care. The study device, the ELIXIR MD system, delivers blue, yellow, red, and near-infrared light and is legally marketed in the United States under a U.S. Food and Drug Administration (FDA) 510(k) clearance, though its use in this study to evaluate reduction of postoperative bruising and swelling is not among its currently cleared uses.
Participants are randomly assigned (1:1) to one of two light therapy schedules: the schedule currently used in the practice, or a new multi-wavelength schedule being studied. Researchers do not know in advance which schedule reduces bruising more; that is the main question this study is designed to answer. The study is not placebo-controlled, because photobiomodulation is already part of routine care at the site; there is no untreated comparison group.
The main measurement is how visible facial bruising is about 7 days after surgery, based on standardized photographs graded by an assessor who does not know which treatment the participant received. The study also looks at facial swelling, pain, patient-reported recovery, and safety (including skin reactions and wound healing).
This is a small pilot study of about 40 participants at a single study site. It is designed to give an early estimate of whether the new schedule helps and to inform a future, larger study. It is not designed or statistically powered to prove that either schedule works.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Scheduled for elective facial plastic surgery at the study site: rhinoplasty, facelift and/or neck lift, blepharoplasty, brow lift, or a combination of these procedures.
* Able and willing to attend the perioperative visits and standardized photography required by the protocol.
* Able to read, understand, and provide written informed consent in English.
Exclusion Criteria:
* Known photosensitivity disorder, or current use of a photosensitizing medication (for example, systemic isotretinoin, tetracyclines, amiodarone, methoxsalen, or systemic photodynamic agents), though this may be up to treating physician discretion.
* Active facial infection or dermatitis at a treatment site.
* History of keloid formation, or an uncontrolled pigmentary disorder (for example, active melasma or post-inflammatory hyperpigmentation under treatment).
* Pregnancy or breastfeeding.
* Therapeutic anticoagulation (for example, warfarin or a direct oral anticoagulant) or high-dose aspirin or nonsteroidal anti-inflammatory drug (NSAID) use that has not been discontinued preoperatively per the site's standard perioperative protocol.
* Inability to provide independent informed consent, or reliance on a legally authorized representative. Adults who lack decisional capacity are not enrolled.
* Concurrent enrollment in another interventional clinical study affecting facial healing or inflammation.
Source: ClinicalTrials.gov (NCT07846631). StuddyBuddy aggregates publicly available trial information.