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

Inclusion criteria

• Males and females between 18 and 65 years of age.
• Subjects requesting primary rhinoplasty and requiring an external approach.
• Subjects willing to undergo treatment with fibrin sealant.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
• Willingness and ability to comply with the PI's standard preoperative and postoperative rhinoplasty instructions.
• Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:

• postmenopausal for at least 12 months prior to study drug administration
• without a uterus and/or both ovaries
• has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
• absence of an other physical condition according to the PI's discretion
• Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Exclusion criteria

• Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
• 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.).
• Subjects with a previous history of rhinoplasty.
• Subjects with a current history of smoking.
• Subjects with a previous history of a bleeding or coagulation disorder .
• Subject with a previous history of a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension.
• Subjects a previous history of diabetes mellitus with glycosylated hemoglobin (HbA1c) > 7.
• Subjects undergoing active treatment for a malignancy.
• Subjects with a previous history of has a connective tissue disorder.
• Subjects with active or chronic skin disorder.
• Subjects with a previous history of Bell's palsy.
• Subjects with a previous history of pathologically or pharmacologically induced immune deficiency.
• Subjects who have received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery.
• Subjects with a known sensitivity to components of FS VH S/D 4 s-apr.
• Subjects with a previous history of healing complications following previous surgeries (eg, hypertrophic scarring).
• Subjects with a significant systemic illness or illness localized to the areas of treatment.
• Subjects with previous history of nasal implants.
• Subjects with previous or current history of nasal infections.
• Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.
• Subjects who have smoked within the two weeks prior to surgery.
• Subjects who have had alcohol or illicit drugs one week prior to surgery.
• Subjects who have eaten or drank anything after midnight the night prior to surgery.
• Subjects with current history of chronic drug or alcohol abuse.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
• Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study.
• Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability.
• 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