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临床试验/NCT05273060
NCT05273060已完成不适用

Regenerative Medicine Approach to Nasal Reconstruction

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
7
试验地点
2
主要终点
Viable nasal reconstruction

研究概览

简要总结

The purpose of this study is to gather information on the safety and effectiveness and compare nasal reconstruction standard planning versus 3D preoperative scanning/printing/planning.

详细描述

Patients with nasal defects from cancer, trauma, prior surgery, or birth often require complex reconstruction. Current techniques involve hand sketched skin templates and/or hand carved cartilage grafts that are formed intraoperatively for nasal reconstruction. This process is time consuming, heavily depends on the surgeon's skill, cannot be standardized, and is difficult to visualize with patients preoperatively. To overcome these barriers and shift surgical paradigms, we will use a regenerative medicine approach to nasal reconstruction to create patient specific and individualized results. We will leverage regenerative medicine techniques of 3D surface mapping, 3D printing and modeling, and new tissue preparation techniques for skin template creation and sculpting of cartilage grafting. Clinically this will improve patient specific outcomes, increase reproducibility, reduce operative times, and allow for an individualized approach to nasal reconstruction. This will be achieved by (1) establishing ideal diced cartilage graft parameters in the laboratory setting for moldable cartilage graft formation. This knowledge will be applied to (2) create diced cartilage grafts for nasal dorsum and tip reconstruction from 3D printed nasal molds. For nasal skin reconstruction, (3) 3D facial scans of patients' preoperatively will be used to generate patient specific templates for skin reconstruction. Ultimately, (4) these regenerative medicine techniques of cartilage and skin reconstruction performed with 3D planning can be shared in an interactive format with patients preoperatively. This will allow patients to be involved in the surgical planning of their nasal reconstruction to increase their autonomy and the individualization of their surgery.

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or female, age range is ≥ 18 to ≤ 100, based on historical surgical experience.
  • Patients undergoing nasal reconstruction.
  • Patients will be identified from the Facial Plastic Surgery clinic of the PI.

排除标准

  • Patients < 18 are excluded because these cases are in combination with providers from PCH and patients have shared/limited postoperative follow up as a result.

结局指标

主要结局

Viable nasal reconstruction

时间窗: 6 months

Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect

次要结局

  • Nasal breathing(6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brittany E. Howard

Principal Investigator

Mayo Clinic

研究点 (2)

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