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临床试验/NCT03717220
NCT03717220已完成不适用

Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps

The Second Hospital of Tangshan0 个研究点目标入组 26 人开始时间: 2008年7月15日最近更新:
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
26
主要终点
Static 2PD test

研究概览

简要总结

Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.

详细描述

For the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • the separate soft tissue defects with exposed bone or tendon in different digits
  • the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
  • necessity to preserve digit length
  • local tissue near the defect can be used as the donor
  • a patient between 15 and 60 years of age

排除标准

  • concomitant injuries to the dorsum of the injured finger
  • a defect < 1.5 cm and>3.5 cm in length
  • a finger degloving injury
  • the defect of the thumb

研究组 & 干预措施

flaps

Other

flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects

干预措施: flap transferring (Procedure)

结局指标

主要结局

Static 2PD test

时间窗: 18 months to 24 months

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

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