The periorbital area is highly vascular and very sensitive to surgical trauma. The dissection and hemostasis modalities used to perform aesthetic eyelid surgery can significantly influence the intensity and duration of postoperative periorbital edema and ecchymosis. These complications not only extend recovery, but may also affect eyelid function and are causal factors for other postoperative periorbital

sequelae.1

This is a prospective, randomized, controlled, double blinded, split face study designed to compare the intensity and duration of periorbital edema and ecchymosis after upper and lower blepharoplasty using the Harmonic® Synergy™ Curved Blade vs. conventional surgical technique using cold steel scalpel/ scissors and electrosurgery. This study was reviewed and approved by an independent, institutional review board prior to initiation and conducted in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and Good Clinical Practices (GCPs).

A total of 20 male and female subjects, age 35-75, were screened using predetermined eligibility criteria, and enrolled for upper and lower eyelid surgery by a single (the same) surgeon. No other concomitant procedures were performed. The dissection and hemostasis modality used to initiate the procedure was randomly assigned to avoid bias with respect to procedural sequence as well as known or unknown subject baseline variables that could affect the outcomes of the study. Surgical techniques including general anesthesia, corneal protectors, volume of incisional infiltration of 1% Lidocaine with epinephrine, full open primary upper and lower eyelid blepharoplasty, application of antibiotic and steroid-containing ointments, and ice packs were standardized for both sides of the face. One set of eyelids was operated with the harmonic and the other set with electrosurgery. The intensity and duration of periorbital edema and ecchymosis were quantitatively and qualitatively evaluated at 1, 2, 3, 5, 7, 10, 14 + 1, 30 + 3, and 60

+ 7 days after surgery across three independent, blinded perspectives:

1) Plastic surgeon (i.e., not the investigator);

2) Patient; and

3) Photographer

Data were recorded into subject source medical records, transcribed onto standardized case report forms, and subsequently entered into a database for tabulation and analysis. The study data is currently being analyzed, the principal investigator (i.e., author of this abstract submission) and the independent, blinded evaluators characterized above have noted significant differences between the treatment groups as illustrated by the attached images. Formal analysis of the study data will be submitted prior to publication/presentation.

FIGURE 1 (below): Postoperative day 2 photograph of patient. Differences in edema and ecchymosis are evident between the patient's left (electrosurgery) and right (harmonic) sides.

FIGURE 2 (below): Postoperative day 3 photograph of patient. Differences in edema and ecchymosis are evident between the patient's left (harmonic) and right (electrosurgery) sides.

References

1. Pacella, S. J., & Codner, M. A. (2010). Minor complications after blepharoplasty: Dry eyes, chemosis,

granulomas, ptosis, and scleral show. Plastic and Reconstructive Surgery, 125(2), 709-718.

Study funded by Ethicon Endo-Surgery, Inc.