Rhinoplasty
Conditions
Brief 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).
Interventions
OTHERAutologous Costal Cartilage Graft
Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
OTHERCostal Cartilage Allograft.
Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
Sponsors
Musculoskeletal Transplant Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Outcome Assessment | Preoperative | Subjective assessment using the Face-Q checklists and scoring for preoperative assessment. |
Secondary
| Measure | Time frame |
|---|---|
| Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc. | 12 months |
| Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures. | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety: occurrence of adverse events (AEs) | 12 months | Evaluation of the occurrence of adverse events (AEs) as documented by the treating physician during the course of treatment and follow-up visits and as reported by the subjects at each Assessment Visit. |
Countries
United States
Outcome results
None listed