A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty

Exclusion Criteria

• •1. Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
• •2. Subjects who are planning a concurrent facial surgery during the operation (eg forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.).
• •3. Subjects with a previous history of rhinoplasty.
• •4. Subjects with a current history of smoking.
• •5. Subjects with a previous history of a bleeding or coagulation disorder .
• •6. Subject with a previous history of a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension.
• •7. Subjects a previous history of diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 7.
• •8. Subjects undergoing active treatment for a malignancy.
• •9. Subjects with a previous history of has a connective tissue disorder.
• •10. Subjects with active or chronic skin disorder.
• •11. Subjects with a previous history of Bell's palsy.
• •12. Subjects with a previous history of pathologically or pharmacologically induced immune deficiency.
• •13. Subjects who have received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery.
• •14. Subjects with a known sensitivity to components of FS VH S/D 4 s-apr.
• •15. Subjects with a previous history of healing complications following previous surgeries (eg, hypertrophic scarring).
• •16. Subjects with a significant systemic illness or illness localized to the areas of treatment.
• •17. Subjects with previous history of nasal implants.
• •18. Subjects with previous or current history of nasal infections.
• •19. Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.
• •20. Subjects who have smoked within the two weeks prior to surgery.
• •21. Subjects who have had alcohol or illicit drugs one week prior to surgery.
• •22. Subjects who have eaten or drank anything after midnight the night prior to surgery.
• •23. Subjects with current history of chronic drug or alcohol abuse.
• •24. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
• •25. Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study.
• •26. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability.
• •27. Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study