The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
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;
- 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
- 否
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
Standard, waterproof dressing applied to wound
干预措施: Smith & Nephew PICO Negative wound pressure versus standard dresing (Device)
Simple dressing
Standard, waterproof dressing applied to wound
干预措施: PREVENA Negative pressure wound versus standard dressing (Device)
PICO Dressing
Negative Wound pressure applied second cohort
干预措施: PREVENA Negative pressure wound versus standard dressing (Device)
PREVENA Dressing
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
Noel Edward Donlon
Specialist Registrar General Surgery
St. James's Hospital, Ireland
