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临床试验/NCT01629602
NCT01629602已完成不适用

Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap

The Second Hospital of Tangshan0 个研究点目标入组 49 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
主要终点
static 2-point discrimination test

研究概览

简要总结

Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. To resolve this problem, we combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For comparison, we also collected a consecutive series of 32 patients with similar injury in the finger treated using a cross finger flap and a secondary free nerve graft.

详细描述

The patients in this study group were required to meet all of the following criteria: soft tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1 to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss and PDN defect. Patients were excluded when they had the following: injury to the course of the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.

研究设计

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

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • soft tissue loss between the midpoint of the distal phalanx and PIP joint; - associated PDN defect 1 to 4 cm in length;
  • single or double PDN defects;
  • simultaneous repair of soft tissue loss and PDN defect.

排除标准

  • injury to the course of the vascular pedicle or the donor nerve;
  • PDN defect less than 1 cm or larger than 4 cm in length;
  • direct PDN repair;
  • thumb neurocutaneous defects.

结局指标

主要结局

static 2-point discrimination test

时间窗: from 18 to 24 months

The test points were at the centers of the radial and ulnar portions of the finger pulp, the flap and the donor sites separately.

次要结局

  • Cold Intolerance Severity Score (CISS) questionnaire(from 18 to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

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