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临床试验/NCT03871023
NCT03871023Unknown不适用

The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds

St. James's Hospital, Ireland2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
2
主要终点
superficial site infection via southampton scoring system (higher score - worse outcome)

研究概览

简要总结

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.

The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.

详细描述

In the era of enhanced recovery, improving modifiable peri-operative and post-operative factors is essential to better patient outcomes. Surgical site complications in the form of wound infections are a major burden to the healthcare system. Negative pressure wound therapy (NPWT) as delivered by a surgical incision management system (SIMS) is a novel approach to improve wound healing when applied to closed incisions.

However, data is limited in its application to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.

In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc, surgical site complications continue to represent a huge healthcare burden.

Aim;

  1. To determine if prophylactic negative pressure wound therapy confers a lower rate of Superficial Site Infection or reduces wound complications in Emergency or Elective Laparotomy wounds thereby improving post-operative patient recovery and reducing healthcare costs.

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
Single (Investigator)

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

  • All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.

排除标准

  • Pregnant patients and those undergoing re-look laparotomies are to be excluded.

研究组 & 干预措施

Simple dressing

Active Comparator

Standard, waterproof dressing applied to wound

干预措施: Smith & Nephew PICO Negative wound pressure versus standard dresing (Device)

Simple dressing

Active Comparator

Standard, waterproof dressing applied to wound

干预措施: PREVENA Negative pressure wound versus standard dressing (Device)

PICO Dressing

Active Comparator

Negative Wound pressure applied second cohort

干预措施: PREVENA Negative pressure wound versus standard dressing (Device)

PREVENA Dressing

Active Comparator

Negative wound presure applied to third cohort

干预措施: Smith & Nephew PICO Negative wound pressure versus standard dresing (Device)

结局指标

主要结局

superficial site infection via southampton scoring system (higher score - worse outcome)

时间窗: 5 days

seroma/haematoma/abscess formation

Wound Dehisence

时间窗: 5 days

disruption of wound continuity

次要结局

  • Length of hospital stay(30 days)
  • Wound healing/Cosmesis(week 6 post op)
  • home care therapy(30days)

研究者

发起方
St. James's Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Noel Edward Donlon

Specialist Registrar General Surgery

St. James's Hospital, Ireland

研究点 (2)

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