跳至主要内容
临床试验/NCT07717138
NCT07717138尚未招募不适用

Study of the Biomechanical and Histological Properties of Septal, Auricular, and Costal Cartilage in the Context of Optimizing Total Nasal Reconstruction

Hôpital NOVO1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
33
试验地点
1
主要终点
Structural Histological Features of Septal, Costal, and Auricular Cartilage

研究概览

简要总结

The purpose of the study is to understand the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and to identify them histologically.

详细描述

Current state of knowledge on the biomechanical properties of human nasal cartilage - implications for tissue engineering and reconstructive surgery

  1. Introduction and clinical context Nasal defects, whether of traumatic, tumoral, dermatological, or congenital origin, constitute a major disfigurement with significant physical and psychosocial repercussions. Nasal reconstruction traditionally relies on autologous grafts - septal, auricular, or costal cartilage - but this approach is limited by donor site morbidity, tissue availability, and the risk of graft failure. Existing alloplastic materials (silicone, Gore-Tex, Medpor high-density polyethylene) exhibit high rates of extrusion and infection, primarily due to mechanical incompatibility with the native tissue. The development of tissue-engineered substitutes thus constitutes a response to an unmet clinical need, provided that precise biomechanical data on the tissues to be replaced are available.
  2. Structure and Histology of Cartilages Used in Nasal Reconstruction 2.1 Nasal Cartilage

The nose is composed of three main cartilages:

The septal cartilage: the central supporting structure of the entire nasal pyramid, directly adjacent to the nasal bones posteriorly. It includes the quadrangular cartilage anteriorly and the vomer elements posteriorly.

The alar cartilages (medial and lateral): mobile structures ensuring the patency of the nasal openings and maintaining the tip of the nose. The superior lateral cartilages: constituting the middle third of the nasal pyramid, and contributing to the stability of the dorsum.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult patients who have undergone septoplasty, rhinoseptoplasty, or otoplasty, and in whom excess cartilage was removed during the surgical procedure.
  • This cartilage, usually destined for disposal as surgical waste, is collected with the patient's consent, in accordance with current ethical and regulatory guidelines.

排除标准

  • Patient refusal

结局指标

主要结局

Structural Histological Features of Septal, Costal, and Auricular Cartilage

时间窗: Through study completion, an average of one year

Structural analysis of cartilage architecture (e.g., chondrocyte distribution/density, extracellular matrix organization, perichondrium integrity) performed ex vivo on surgical waste tissue samples by histological staining, compared across the three cartilage types. No measurement is performed on participants in vivo.

次要结局

  • Young's Modulus of Septal, Costal, and Auricular Cartilage(Through study completion, an average of one year)
  • Young's Modulus of Cartilage by Type, Patient Age, and Sex(Through study completion, an average of 1 year)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验