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 range
18 Years – 60 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.