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临床试验/NCT02954835
NCT02954835已完成4 期

Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery

Englewood Hospital and Medical Center2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
2
试验地点
2
主要终点
Infection rate

研究概览

简要总结

The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

详细描述

This is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. Patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon. The patients with Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. The Primary Objective of this study is to see if using negative pressure therapy decreases the rate of infection. The Secondary Objectives will include multivariate analysis to understand which patients may have a compounded benefit from Prevena (e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage and will be used in this study for on-label purposes.

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

入选标准

  • Patients undergoing vascular surgery with a groin incision.

排除标准

  • Allergy to silver.

结局指标

主要结局

Infection rate

时间窗: 17 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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