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临床试验/NCT01778296
NCT01778296已完成不适用

Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap

The Second Hospital of Tangshan1 个研究点 分布在 1 个国家目标入组 12 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
12
试验地点
1
主要终点
Discriminatory Sensation of the Flap

研究概览

简要总结

The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal digital island flap can be used for repairing the defect of adjacent finger, but the limited length of the pedicle precludes its use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal branch of the digital nerve can be used as an alternative to resolve this problem.

详细描述

At final follow-up, we measured the sensibility of the flaps using the Semmes-Weinstein monofilament test and the static 2-point discrimination test. The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stopped at 4mm as a limit of 2PD and considered this normal.

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

  • the soft tissue defects involving the middle phalanx, the proximal interphalangeal joint, or both;
  • a defect greater than or equal to 2 cm in length;
  • a patient between 15 and 60 years of age.

排除标准

  • concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that precluded its use as donor site;
  • injuries to the course of donor nerve branch;
  • a defect less than 1.5 cm in length;
  • a fingertip or pulp defect;
  • a soft tissue defect of the thumb.

结局指标

主要结局

Discriminatory Sensation of the Flap

时间窗: 18 months to 24 months

Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent \<6 mm; good 6-10 mm; fair 11-15 mm; poor \>15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.

次要结局

  • Cold Intolerance(18 months to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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