Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient Outcome Assessment
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Costal Cartilage Allograft
Patients undergoing rhinoplasty will receive costal cartilage allograft.
干预措施: Costal Cartilage Allograft. (Other)
Autologous Costal Cartilage Graft
Patients undergoing rhinoplasty will receive autologous rib graft.
干预措施: Autologous Costal Cartilage Graft (Other)
结局指标
主要结局
Patient Outcome Assessment
时间窗: 12 months
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Patient Outcome Assessment
时间窗: Preoperative
Subjective assessment using the Face-Q checklists and scoring for preoperative assessment.
Patient Outcome Assessment
时间窗: 3 months post-operative
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Patient Outcome Assessment
时间窗: 6 months post-operative
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
次要结局
- 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)