The AVATAR Trial: Applying VAcuum To Accomplish Reduced Wound Infections in Laparoscopic Pediatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The rate of postoperative wound infections at the umbilical port site.
研究概览
简要总结
Postoperative pain and time taken to return to normal activities after laparoscopic surgery are significantly shorter. Wound infections still occur and contribute to prolonged hospital stays and morbidity. Typically, port incision sites are covered with a standard dressing (approximating strips and a gauze). Although the umbilical wound infection rate in laparoscopic surgery is considered to be low, a recent study by Muensterer and Keijzer showed that the umbilical wound infection rate after single incision laparoscopic appendectomy in children is approximately 7%. In the same retrospective study, the investigators demonstrated that a simple low cost vacuum dressing can significantly reduce the infection rate. The aim of this prospective randomized controlled trial is to determine if the simple vacuum dressing is superior to a standard dressing in reducing laparoscopic postoperative umbilical wound infections. All patients under 17 years of age undergoing a laparoscopic operation in the Children's Hospital will be randomized to a standard postoperative dressing or a standard postoperative dressing with vacuum applied to it. The vacuum will be applied with a 22g needle on a 10ml syringe passed percutaneously from outside the dressing into the gauze and the air around the gauze is evacuated. The umbilical wounds will be evaluated 8-10 days postoperatively in the clinical research unit of the Manitoba Institute of Child Heath according to a standardized and validated wound evaluation tool from the Canadian Center for Disease Control. Primary outcome measure in this study is postoperative wound infection. A sample size calculation using the retrospective data demonstrated that the investigators need 275 patients in each group for the Chi-squared test to have an 80% chance of detecting a difference in wound infection rate of 6% at the 5% level of significance. Based on the annual number of laparoscopic operations in the Children's Hospital (around 400) the investigators anticipate completing the inclusion of patients within a two-year period.
详细描述
The AVATAR Trial: Protocol
Applying VAcuum To Accomplish Reduced wound infections in laparoscopic pediatric surgery
Surgical Site Infections (SSIs) are the most common complication of surgery worldwide and one of the leading causes of morbidity and mortality in surgical patients. Literature has shown that patients who develop an SSI are five times more likely to require readmission to hospital within 30 days, 60% more likely to require ICU admission, and twice as likely to die. SSIs also carry a significant financial burden to the healthcare system. Annually in the US, SSIs account for over 900 million dollars spent in-hospital and $1.6 billion overall in health care. The average risk of developing an SSI from any surgical procedure is 1-4%. A landmark study by Horan, et al. in 1992 defined SSIs as any infection occurring within 30 days of an operation or up to 1 year if an implanted device was used. Infections were further classified as: superficial incisional, deep incisional, or organ/space, with diagnostic criteria on physical exam to support each category. This criterion for SSI diagnosis has since become the standard definition at the American Center for Disease Control (CDC) and worldwide.
Table 1: CDC Definition of an SSI.
Superficial Incisional SSI:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 0-17 years old
- •any emergency or elective laparoscopic procedure requiring an umbilical port
排除标准
- •immunocompromise (acquired or iatrogenic)
- •malignancy
- •requiring blood transfusion within 6 weeks of surgery
- •history of splenectomy
- •significant comorbid conditions, such as severe cardiopulmonary disease
- •presence of any chronic abdominal wound, cellulitis, or enterocutaneous fistula
- •pregnancy
- •BMI > 30
- •inability to attend follow up
- •language barrier
结局指标
主要结局
The rate of postoperative wound infections at the umbilical port site.
时间窗: prospective
The primary outcome measure: postoperative wound infection at the umbilical port site will be blindly evaluated at 8-10 days postoperatively according to the criteria provided by the CDC by an independent nurse from the clinical research unit at the Manitoba Institute of Child Health (MICH) The timeframe for follow up was chosen because it will minimize the likelihood of patients being lost to follow up while maximizing the opportunity for detection of infection, since the majority of SSIs are apparent by postoperative day 3-5.
次要结局
未报告次要终点
研究者
Dr. Richard Keijzer
assistant professor
University of Manitoba
