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临床试验/ChiCTR1900027453
ChiCTR1900027453已完成Unknown

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

未提供2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2016年1月30日最近更新:

试验速览

阶段
Unknown
状态
已完成
入组人数
420
试验地点
2
主要终点
Patient Reported Outcomes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
Single

入排标准

年龄范围
18 至 80(—)
性别
All

入选标准

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

排除标准

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

研究组 & 干预措施

1

NPWT

2

Standard Gauze dressing

结局指标

主要结局

Patient Reported Outcomes

时间窗: 1 year

Clinical Outcome

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
未提供

研究点 (2)

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