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临床试验/NCT02167646
NCT02167646已完成不适用

Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

The Second Hospital of Tangshan1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2008年1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
73
试验地点
1
主要终点
Static 2PD test

研究概览

简要总结

Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

详细描述

Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

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
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
  • the defect associated with the transected digital nerves in both sides
  • a defect greater than 1.5 cm
  • a patient aged 15 to 60 years

排除标准

  • injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
  • injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
  • a defect less than or equal to 1.5 cm
  • patient age < 15 years or > 60 years

结局指标

主要结局

Static 2PD test

时间窗: 18 months to 24 months after surgery

We use a Disk-Criminator to test two nearby points when touching the flap

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 (1)

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