A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery

Exclusion Criteria

• •1. Subjects with breast implants or history of breast implants
• •2. Subjects undergoing breast surgery requiring breast implants
• •3. Subjects requiring nipple grafting using any technique
• •4. Subjects with a history of infection in the past 6 months in the intended area of incision
• •5. Subjects with breast tattoos in the intended area of the incision
• •6. Subjects with known skin sensitivity to Tegaderm™
• •7. Subjects with a history of keloids
• •8. Known conditions of collagen vascular diseases
• •9. Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or autoimmune disease. Examples include but are not limited to:
• •1. Renal insufficiency as an estimated GFR, which is \< 30 mL/min/1.7m2
• •2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
• •3. Hepatic insufficiency defined as total bilirubin \> 2 mg/dL or serum albumin \< 25 g/L
• •4. Hemoglobin \< 9 g/dL
• •5. Hematocrit \< 30%
• •6. Platelet count \< 100,000 μL
• •10. Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
• •11. Current treatment with systemic corticosteroids (\>15 mg/day). Washout period is 30 days prior to screening
• •12. Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening
• •13. Previous history of radiation therapy to the chest
• •14. Known inability to complete required study visits during study participation
• •15. A psychiatric condition (e.g., suicidal ideation), chronic alcohol consumption, or drug abuse problem determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
• •16. Use of any investigational drug or therapy within the 28 days prior to screening
• •17. History of previous breast surgeries in the area where the incisions are to be made
• •18. Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding
• •19. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study
• •20. Any areolar abnormalities that are deemed clinically significant by the Investigator