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临床试验/NCT05455801
NCT05455801已完成不适用

Randomized Study on the Efficacy of Negative Pressure Wound Therapy (NPWT) in the Prevention of Surgical Site Complications

Hospital Universitario Central de Asturias2 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
271
试验地点
2
主要终点
surgical site complications

研究概览

简要总结

Surgical site complications generate a series of consequences that prolong hospital stay, increase interventions and procedures, and consequently considerably increase healthcare costs. Hence, the importance of studying measures to reduce these complications and the most feared of them is surgical site infection. The objective of the study is to analyze the complications of the surgical site in a group of participante with risk factors for developing them after undergone abdominal surgery in the period described.

详细描述

All non-consecutive participants operated on in a hospital were included, both those who, based on a protocol prepared by the investigators unit, were classified as having no risk of developing complications, low risk or high risk. Partfipants classified as low and high risk, after their consent to participate in the study, entered to form part of it. This participanta were classified before surgery according to the risk factors of themselves and of the procedure, and those at risk were randomized to treatment with a negative pressure therapy dressing or no treatment, and a cure was performed with a conventional dressing. The participants classified as not at risk of complications were not included in the study. In this way the investigators tried to analyze if the intervention with the negative pressure therapy dressing reduced the complications of the surgical site.The primary objective was to analyze the reduction of surgical site infections in participants treated with negative pressure therapy compared to those treated with conventional dressing. As secondary objectives the investigators proposed to measure other complications in both groups and the hospital stay.

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

入选标准

  • patients with risk factors for developing surgical site complications
  • undergo abdominal surgery
  • consent of the patient to participate in the study

排除标准

  • non-consent of the patient to participate in the study
  • patients without risk of developing surgical site complications

结局指标

主要结局

surgical site complications

时间窗: 30 days after surgery

development of surgical site infection of wound seroma, skin dehiscence, wound necrosis

次要结局

  • length of hospital stay(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Moreno Gijon

Principal Investigator

Hospital Universitario Central de Asturias

研究点 (2)

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