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临床试验/NCT03566641
NCT03566641撤回不适用

A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery

University of Toledo Health Science Campus2 个研究点 分布在 1 个国家开始时间: 2018年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Surgical site infection

研究概览

简要总结

A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing

详细描述

The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Out study is a single-blinded randomized clinical trial. The patient will be informed about the type of dressing used for their wound care, but the investigator and the outcome assessor will be blinded for which type of dressing used for each participant patient.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consent for participation from the patient or his legal representative

排除标准

  • Currently infected wounds
  • Patients with history of immunosupression
  • Pregnancy

结局指标

主要结局

Surgical site infection

时间窗: 30-day postoperative period

The rate of occurrence of signs and symptoms of surgical site infection

次要结局

  • cost of hospitalization(6 months)
  • length of total hospital stay(6 months)
  • Rate of reoperation(30-day postoperative period)

研究者

发起方
University of Toledo Health Science Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Munier Nazzal, M.S. M.D

Investigator

University of Toledo Health Science Campus

研究点 (2)

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