Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty (NCT05566808) | Clinical Trial Compass
CompletedNot Applicable
Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty
United States50 participantsStarted 2017-03-01
Plain-language summary
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).
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.