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临床试验/NCT01927003
NCT01927003已完成不适用

Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases

The Second Hospital of Tangshan1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
The Static 2-point discrimination test

研究概览

简要总结

Multiple digital injuries are often complex and severe, and the commonly used local and regional flaps may not be feasible. The authors reconstruct soft tissue defects of the fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.

详细描述

At final follow-up, we measure the sensibility of the flaps using the static 2-point discrimination test. The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent <6 mm, good 6-10 mm, fair 11-15 mm, poor >15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopp at 4mm as a limit of 2PD and consider this normal. The measurements are performed at a single time point at final follow up.

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 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • the injured and adjacent fingers are unable to be used as the donor due to multiple digital injuries
  • a soft tissue defect > 1.5 cm in length with exposed bone or tendon
  • the reverse DMA flap may not be appropriate for tissue reconstruction due to the concomitant injuries or due to the limitation of the rotation arc
  • a patient between 15 and 60 years of age

排除标准

  • concomitant injuries involved all the finger that precluded their use as donor sites
  • a defect less than 1.5 cm in length
  • injuries to the course of the vascular pedicle

研究组 & 干预措施

Surgical flap

Experimental

Dorsal digito-metacarpal flap is based on the dorsal digital artery and dorsal metacarpal artery.

干预措施: Dorsal digito-metacarpal flap (Procedure)

结局指标

主要结局

The Static 2-point discrimination test

时间窗: 18 to 24months

The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent \<6 mm, good 6-10 mm, fair 11-15 mm, poor \>15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and considered this normal. The measurements are performed at a single time point at final follow up.

次要结局

  • Patient satisfaction(18 to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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