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【ChiCTR1900027453】Negative pressure wound therapy versus conventional dressing for open fractures in lower extremity trauma. A multicentric randomized controlled trial

基本信息
登记号

ChiCTR1900027453

试验状态

结束

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2019-11-14

临床申请受理号

/

靶点

/

适应症

wound

试验通俗题目

Negative pressure wound therapy versus conventional dressing for open fractures in lower extremity trauma. A multicentric randomized controlled trial

试验专业题目

Negative pressure wound therapy versus conventional dressing for open fractures in lower extremity trauma. A multicentric randomized controlled trial

申办单位信息
申请人联系人
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申请人名称
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联系人邮箱
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联系人邮编

75510

联系人通讯地址
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临床试验信息
试验目的

The aim of this multicenter randomized controlled trial is to compare standard dressing versus negative pressure wound therapy for adults with an open fracture of lower limb.

试验分类
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试验类型

随机平行对照

试验分期

其它

随机化

A system-generated randomization algorithm was created by the research office and delivered by a dedicated officer to ensure that the allocation sequence was concealed. The individual patient was allocated treatment on a non-probability consecutive basis, stratified for Gustilo-Anderson grade.

盲法

single blinding

试验项目经费来源

试验范围

/

目标入组人数

206;214

实际入组人数

/

第一例入组时间

2016-01-30

试验终止时间

2018-12-31

是否属于一致性

/

入选标准

1. Patient 18 years and older with an open fracture of the lower limb were eligible; 2. Wounds were graded using Gustillo-Anderson classification, patients with GA-II till III-C were included in the study; 3. In order to enter the trial, the patient had to present within 72 hours of the injury.;

排除标准

1. GA – I was excluded due to lack of need for primary intervention under study in most cases; 2. Patients with altered consciousness and any known contraindications to general anesthesia were excluded from the study.;

研究者信息
研究负责人姓名
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试验机构

Allah Rakhio Jamali

研究负责人电话
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研究负责人邮箱
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研究负责人邮编

75510

联系人通讯地址
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