BACKGROUND: A novel medical device that has been approved by the Food and Drug Administration is available for treatment of postsurgical edema. The device emits a low-level, pulsed electromagnetic energy field, which modulates resting cell membrane potential, allowing a return to physiologic resting membrane potential. OBJECTIVE: To investigate the benefits of electromagnetic energy in eyelid wound healing. METHODS:Fifty-seven individuals participated in this randomized, double-blinded study. All patients underwent upper blepharoplasty. At the postoperative visit, patients rated pain, edema, and ecchymosis, and the physician rated edema, ecchymosis, and erythema. RESULTS: There was no difference (p = .76) in patient pain rating when comparing placebo (1.6) with the patch (1.3). Patients reported 6% less edema (p = .11) and 10% less ecchymosis (p = .17) with the active patch eye than in control eye. The physician-graded edema, ecchymosis, and erythema had a mean Likert-type scale difference between placebo and active eyes of -0.3 (p = .12), -0.3 (p = .17), and -0.2 (p = .004) respectively. CONCLUSION: The use of pulsed electromagnetic energy did not have an effect on postoperative pain, edema, or ecchymosis as rated by patients and physicians. There was a statistically significant reduction in physician-graded erythema for active patch eyes versus placebo.
RCT Entities:
BACKGROUND: A novel medical device that has been approved by the Food and Drug Administration is available for treatment of postsurgical edema. The device emits a low-level, pulsed electromagnetic energy field, which modulates resting cell membrane potential, allowing a return to physiologic resting membrane potential. OBJECTIVE: To investigate the benefits of electromagnetic energy in eyelid wound healing. METHODS: Fifty-seven individuals participated in this randomized, double-blinded study. All patients underwent upper blepharoplasty. At the postoperative visit, patients rated pain, edema, and ecchymosis, and the physician rated edema, ecchymosis, and erythema. RESULTS: There was no difference (p = .76) in patientpain rating when comparing placebo (1.6) with the patch (1.3). Patients reported 6% less edema (p = .11) and 10% less ecchymosis (p = .17) with the active patch eye than in control eye. The physician-graded edema, ecchymosis, and erythema had a mean Likert-type scale difference between placebo and active eyes of -0.3 (p = .12), -0.3 (p = .17), and -0.2 (p = .004) respectively. CONCLUSION: The use of pulsed electromagnetic energy did not have an effect on postoperative pain, edema, or ecchymosis as rated by patients and physicians. There was a statistically significant reduction in physician-graded erythema for active patch eyes versus placebo.