Application of PREVENA (Surgical Incision Protection System) in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy: A Randomized Controlled Trial (PRIC Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy
研究概览
简要总结
Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy and colostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications.
There have been comparative studies in the use of negative pressure wound therapy in reducing surgical site infections.
PREVENA Incision Management System is a type of disposable, customizable and powered negative pressure system designed to help manage and protect surgical incisions and their surrounding environment. It is now commonly used as a surgical wound dressings in the setting of vascular surgeries, post-cesarean infections and colorectal resections.
Our study is designed as a randomised controlled trial to examine if PREVERA therapy as a NPWT is more superior than conventional dressings in reducing the rate of surgical site infections.
详细描述
Background:
Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications.
The use of Negative Pressure Wound Therapy (NPWT) is one strategy that has been extensively studied in reducing the rate of surgical site infections.
PREVENA Therapy is a form of Incisional Negative Pressure Wound Therapy (INPWT) that has been widely used in the management of closed surgical incisions. They are delivered as prophylactic measures in preventing surgical complications such as surgical site infections.
Trial Design:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years old
- •Patients undergoing elective reversal of ileostomy/colostomy
- •Patients who agree to consent to inclusion and follow-up protocol
排除标准
- •Patients who do not fulfil study protocol
- •Dressings being removed outside defined time periods
- •Patients who do not attend for regular outpatient follow up appointments
结局指标
主要结局
To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy
时间窗: Four to Six weeks
The investigators will be assessing and measuring the incidence of surgical site incidence on follow up appointments
次要结局
- To measure the time to wound healing(One to Four weeks)
- To measure surgical site infection incidence on day 5 post reversal ileostomy/colostomy (or earlier, if deemed fit for discharge prior to day 5)(Five days post reversal ileostomy/colostomy)
研究者
Michael Kelly
Consultant Colorectal Surgeon
St. James's Hospital, Ireland