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临床试验/NCT01767727
NCT01767727已完成不适用

Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

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3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
12
试验地点
1
主要终点
static two-point discrimination

研究概览

简要总结

Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.

详细描述

At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

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 patient who had separate soft tissue defects in different fingers in same hand;
  • the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
  • local tissue near the defect is uninjured; and
  • a patient between 15 and 60 years of age.

排除标准

  • concomitant injuries to local tissue around the defect that precluded its use as donor site;
  • 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

Surgical flap

Other

Surgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects.

干预措施: Soft tissue coverage (Procedure)

结局指标

主要结局

static two-point discrimination

时间窗: postoperative 18-24 months

The test points are at the center of the flap.Each area is tested 3 times with a Discriminator. We stopp at 4 mm as a limit of two-point discrimination and consider this normal.

次要结局

  • Cold intolerance of the injured finger(Postoperative 18-24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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