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临床试验/NCT03193983
NCT03193983已完成不适用

V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017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
60
试验地点
1
主要终点
quick DASH score

研究概览

简要总结

Fingertip is a complex structure that is responsible for the fine function of the fingers and the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious condition that if untreated properly could lead to significant functional disability and disuse of the injured finger. Up to date, defining the best treatment option for this injury remains controversial. Hand surgeons are divided between proponents of flap coverage and conservative treatment, driven by beliefs, training programs and financial aspects. After recently reviewing the literature for the current best evidence and fundamentals of conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed out to the necessity for implementing controlled trials to compare both ways of treatment.

详细描述

The purpose of this study is to determine the efficacy and the results of occlusive dressing in treating fingertip injuries in comparison to flaps with much concern to certain factors that are closely related to our locality including patient compliance for regular follow up , functional outcome , time to return to work and its socioeconomical impact and cosmetic results .

Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.

Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • a. Inclusion criteria:
  • Age Adults 12 - 60 years
  • Diagnosis of fingertip injury with exposed bone (Allen type 2, 3 or 4) in any finger.
  • Informed consent obtained by the patient.

排除标准

  • · Old or complicated fingertip injuries.
  • Non-exposed bone fingertip injury (Allen type1).
  • Patients with severe debilitating disease.

结局指标

主要结局

quick DASH score

时间窗: 6 months

A questionnaire consisting of eleven items that test the functional recovery following upper limb injury

次要结局

  • The presence of nail deformity.(6 months)
  • Pulp volume compared to the contralateral finger: on lateral X-ray(6 months)
  • presence of painful neuroma(6 months)
  • Sensory related outcome in the form of Two point discrimination test (Weber index)(6 months)
  • Finger length: expressed as a shortage in mm. compared to contralateral finger.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Abdelnasser Abdelfatah Farghay

Assiut University , resident doctor at orthopedic and trauma department assiut university hospital

Assiut University

研究点 (1)

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