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 such as chemosis.[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).
Methods/Technique:
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 upper and lower 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 occurrence of chemosis was also monitored and recorded.
Results/Complications:
20 patients completed the study, 16 women and 4 men. Average age was 54.1 years and all were caucasian. A review of the study data confirms significant differences between the treatment groups related to chemosis, edema, and ecchymosis as illustrated by the attached images. Chemosis occurred in 4 instances on the Harmonic side and 7 instances on the electrosurgery side. Formal analysis of the study data will be submitted prior to publication/presentation. There we no major complications. There were no lid malpositions or ectropions.
FIGURE 1 (below): Postoperative day 2 photograph of patient. Differences in edema are evident between the patient’s left (harmonic) and right (electrosurgery) sides.
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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.
Conclusion:
Use of Harmonic in eyelid surgery resulted in less bruising, less edema, less chemosis, and higher patient satisfaction when compared to electrosurgery. The results of this feasibility study warrant further investigation into the potential benefits of the use of Harmonic in eyelid surgery.
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.
*Some data from this study was presented at Plastic Surgery 2010 in Toronto at a scientific session. That presentation included results related to surgical times, patient satisfaction, and the photographer’s measurement of ecchymosis. If accepted for presentation at ASAPS, a different set of results related to the occurrence of chemosis and differences in edema will be presented (representing data and results that were not previously presented).
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