To evaluate its safety and efficacy in reducing bruising and swelling after plastic surgery, SinEcch™ underwent a 3-year Post Marketing Surveillance (PMS) Study conducted by WooilPharm in South Korea from April 2010 to December 2012 – a requirement for receiving permanent approval as a prescription drug in South Korea.
The PMS Study determined that SinEcch™ is “a very effective drug for reducing bruising and swelling” with no reported cases of side effects.1 Based on these results, the Korean FDA concluded that SinEcch™ is safe and effective for reducing post-operative bruising and swelling following plastic surgery.
PMS Study Methods Summary
Purpose: Evaluate the safety and effectiveness of SinEcch™ as a post-op medication to reduce bruising and swelling following plastic surgery.
Research Institutions: The Study was conducted in 19 health care institutions including university hospitals, general hospitals, and plastic surgery clinics.
Survey Population: 650 plastic surgery patients were involved. The patient population included men and women whose ages ranged from 15 to over 65 years. 57 kinds of surgeries were performed. 62% of the patients took concomitant medications; of these, 28% used antibiotics and 19% used anti-inflammatory analgesics.
PMS Report Summary
Within 8 days following the surgical procedure, a comprehensive evaluation ranked each patient’s bruising and swelling as being either “improved,” “unchanged,” or “aggravated.” The PMS Study found that 100% of the 650 patients saw improvement in their swelling and bruising after using SinEcch™ (Tables 8-10). 75% saw very good or excellent improvement with their bruising, with 32% having no bruising (Table 8). 72% saw very good or excellent improvement with their swelling, with 18% having no swelling (Table 9). No adverse effects were reported.
1 SINECCH Capsule PMS (Post Marketing Surveillance) Report, WooilPharm Co., Ltd., Seoul, Rep. of South Korea, June 14, 2013
When assessing the role of concomitant medications in the recovery progress, the p-values indicating the effectiveness of SinEcch™ for reducing bruising and swelling were 0.002 and 0.028 respectively (Tables 16 and 17).
SinEcch™ was found to be both safe and effective by the Korean FDA to reduce post-surgical bruising and swelling, as all patients saw improvement and over 72% saw very good or excellent results. Regardless of whether concomitant medications were used or not, SinEcch™ was shown to be statistically significant in the reduction of bruising and swelling.