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临床试验/NCT05716490
NCT05716490已完成不适用

Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial

Centro Hospitalar do Tâmega e Sousa1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Surgical site infection

研究概览

简要总结

The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.

详细描述

A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.

Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.

Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).

Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith & Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.

Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients proposed for emergency laparotomy

排除标准

  • Contra-indication for iNPWT
  • Irreversible disease diagnosis with expected short term mortality
  • Need for a staged procedure

结局指标

主要结局

Surgical site infection

时间窗: 30 days

Surgical site infection following emergency laparotomy

次要结局

  • Surgical site occurrences(30 days)

研究者

发起方
Centro Hospitalar do Tâmega e Sousa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo José Maia Azevedo Costa

Principal investigator, general surgery resident

Centro Hospitalar do Tâmega e Sousa

研究点 (1)

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