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临床试验/NCT06504173
NCT06504173已完成不适用

Use of Diced Cartilage for Management of Internal Mammary Vessel Exposure Sites in Autologous Breast Reconstruction

ISAR Klinikum2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2024年1月1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
入组人数
173
试验地点
2
主要终点
Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area

研究概览

简要总结

Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.

详细描述

This retrospective, single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023. Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy (DC vs. DCR). The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC. The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging (MRI; > 6 months post-op) and photographic documentation (6-month follow-up).

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
  • MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

排除标准

  • Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
  • Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023

结局指标

主要结局

Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area

时间窗: October 2021 to June 2023

the sinking depth of epicostal soft tissue into the space of rib segment resection on axial planes in Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

次要结局

  • Visual contour deficit of the recipient vessels area(October 2021 to June 2023)

研究者

发起方
ISAR Klinikum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Paul Pfeiler, MD

Consultant

ISAR Klinikum

研究点 (2)

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