Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures

This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).

Inclusion Criteria:

• Subject is scheduled to undergo a reconstructive or cosmetic surgical procedure to alter the appearance of the nose that is anticipated to require a cartilage graft.
• Subject is willing to sign an informed consent.
• Subject is a non-smoker or has stopped smoking at least 6-weeks prior to inclusion in the study.
• Subjects must agree to forgo any treatment, medical or non-medical, to the area treated in this study, for the duration of the 1-year post-treatment evaluation period, unless there is prior approval from the investigator.

Exclusion Criteria:

• Presence of significant endocrine, immunologic, dermatologic or psychiatric abnormalities that would render the subject an inappropriate candidate for the study.
• Presence of any malignancy not considered cured in the midface area specifically (no evidence of cancer recurrence in the previous five years).
• History of radiation to the area(s) to be treated in the study.
• Subjects taking chronic steroids (injected or oral) or other immune modulators.
• Subjects with a history of skin sensitivity (dermatitis) to either the suture materials or dressings to be utilized during the course of this study.
• Subjects with skin conditions that could result in poor healing or widened scars.