Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

MTF Biologics

Status

Completed

Conditions

Rhinoplasty

Treatments

Other: Autologous Costal Cartilage Graft

Other: Costal Cartilage Allograft.

Study type

Interventional

Funder types

Other

Identifiers

NCT05566808

MTF Profile Study

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.