Clinical Research Directory

Perioperative Photobiomodulation in Facial Plastic Surgery

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.