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临床试验/NCT04529330
NCT04529330招募中不适用

Acute Compartment Syndrome

Hebei Medical University Third Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
the time when the blister appeared

研究概览

简要总结

Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. The presence of clinical assessment (5P) always means the necrosis of muscles and was the most serious or irreversible stage of ACS. Besides pressure methods, the threshold of pressure identifying ACS was also controversial.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fracture patients with Schatzker V and VI,
  • Who were older than eighteen years.

排除标准

  • The exclusion criteria were pathologic, extra-articular proximal tibial fracture,
  • Patients who was eighteen years or younger.
  • Patients treated with other implant,
  • underwent conservative management were also excluded.

结局指标

主要结局

the time when the blister appeared

时间窗: up to 4 weeks

The relative data was collected about the time when the blister appeared after injury

No non-anatomic gap or step (larger than 5 mm)

时间窗: through study completion, an average of 1 year

The relative data was collected about complications

secondary loss of reduction

时间窗: through study completion, an average of 1 year

The relative data was collected about complications

superficial wound problems

时间窗: through study completion, an average of 1 year

The relative data was collected about complications

blister skin immunochemistry and immunofluorescence analysis

时间窗: through study completion, an average of 1 year

CK1, 5, 10, claudin 1, 2 and occludin as determined by immunochemistry analysis, and skin barrier proteins; claudin 1, 2 and occludin was determined by immunofluorescence analysis and qPCR.

injury mechanism

时间窗: up to 1 weeks

The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing

time to reconstructive surgery

时间窗: time to when the surgery was conducted after 2 weeks

The relative data was collected about time to reconstructive surgery

union time

时间窗: through study completion, an average of 1 year

The relative data was collected about union time

Deep venous thrombosis

时间窗: through study completion, an average of 1 year

The relative data was collected about complications

次要结局

  • chloride levels(through hospitalization completion, an average of 1 month)
  • UREA levels(through hospitalization completion, an average of 1 month)
  • CK levels(through hospitalization completion, an average of 1 month)

研究者

发起方
Hebei Medical University Third Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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