Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

Study Overview
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Brief Summary
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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).

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

Conditions
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Rhinoplasty

Intervention / Treatment
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* Other: Autologous Costal Cartilage Graft
* Other: Costal Cartilage Allograft.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Autologous Costal Cartilage Graft<br>Patients undergoing rhinoplasty will receive autologous rib graft. | Other: Autologous Costal Cartilage Graft<br>* Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.<br>|
| Other: Costal Cartilage Allograft<br>Patients undergoing rhinoplasty will receive costal cartilage allograft. | Other: Costal Cartilage Allograft.<br>* Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for preoperative assessment. | Preoperative | 
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for post-operative assessments. | 3 months post-operative | 
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for post-operative assessments. | 6 months post-operative | 
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for post-operative assessments. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |