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临床试验/NCT02102035
NCT02102035已完成不适用

Direct and Reversed Dorsal Digital Island Flaps: A Review of 65 Cases

The Second Hospital of Tangshan1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011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
65
试验地点
1
主要终点
Static 2-point discrimination test

研究概览

简要总结

Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The study reports reconstruction of small to moderate defects of the fingers with the direct and reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap and joint motion.

详细描述

At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) test. Active motion of the joints is measured using a standard hand goniometer. For the direct DDIF, total active motion is calculated as the sum of degrees of active flexion of the interphalangeal and the metacarpophalangeal joints subtracted from the degrees of extension deficit. For the reversed DDIF, total active motion of the donor finger is calculated as the sum of degrees of active flexion of the proximal and distal interphalangeal joints subtracted from the degrees of extension deficit.

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

入选标准

  • a defect greater than or equal to 1.5 cm in length
  • the defects on the dorsal and lateral aspects of the fingers
  • the defects located between the distal 1/2 of the middle phalanx and the tip of the finger
  • a patient between 15 and 60 years of age.

排除标准

  • injuries involving the donor sites or the course of the vascular pedicle
  • a defect less than 1.5 cm in length.

结局指标

主要结局

Static 2-point discrimination test

时间窗: 16 to 24 months

The test points are at the center of the flap. Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of static 2-point discrimination test and consider this normal.

次要结局

  • Total active motion(16-24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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