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临床试验/NCT04818190
NCT04818190Unknown不适用

DIEP Flap Sensory Recovery Following Direct Neurotization in Breast Reconstruction - A Blinded Prospective Study

University of Manitoba2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Sensory recovery to neurotized DIEP flap

研究概览

简要总结

The purpose of this study is to compare the sensory return of DIEP flaps with nerve connection to DIEP flaps with no nerve connection to see which is better.

This research is being done because the presence of sensation in a reconstructed breast has been shown to improve patient-related quality of life following mastectomy reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin.

详细描述

The Deep Inferior Epigastric Perforator (DIEP) flap is the current standard of care in breast reconstruction. The DIEP flap does not normally have sensation restored. The presence of sensation in a reconstructed breast has been shown to improve patient-rated quality of life following mastectomy and reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin. As such, the investigators aim to perform a prospective randomized single-blinded trial to evaluate sensory return to DIEP flaps following nerve coaptation.

A blinded, prospective study will be performed involving Manitoban women over 18 years undergoing bilateral breast reconstruction with DIEP flaps. The women will have one breast reconstructed in the standard of care (DIEP flap with no nerve coaptation) and one breast reconstructed with both DIEP flap and sensory nerve coaptation; the side of coaptation will be randomized. Objective sensibility to the breast will be tested pre- and post-operatively (3, 6, 12 months) using the Pressure Specified Sensory Device (PSSD). Patients will also complete the Breast Q questionnaire postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • female subjects older than 18
  • scheduled for immediate bilateral breast reconstruction following bilateral non-nipple sparing mastectomy
  • using DIEP free flap reconstruction
  • with a large skin paddle

排除标准

  • pre-operative radiation or chemotherapy was performed
  • post-operative radiation or chemotherapy is planned
  • reconstruction is performed in a delayed fashion
  • a nerve conduit is necessary for nerve coaptation

结局指标

主要结局

Sensory recovery to neurotized DIEP flap

时间窗: 12 months post-operatively

Sensory recovery measured using Pressure Specified Sensory Device

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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