The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention
研究概览
简要总结
The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing
详细描述
PRIMARY OBJECTIVES:
I. To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.
ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy
- •The scheduled procedure will be performed via midline laparotomy
- •The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
- •Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
排除标准
- •Emergent cases will not be included in the study
- •Pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures
- •Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded
- •Patients on chronic immunosuppressive medications, including steroids, within the past three months
- •Patients with a history of skin allergy to iodine or adhesive drapes
- •The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study
研究组 & 干预措施
Arm I (SSD)
Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.
干预措施: wound care management (Procedure)
Arm II (NPT)
Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.
干预措施: wound care management (Procedure)
结局指标
主要结局
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention
时间窗: 30 days
Results will be analyzed initially using descriptive statistics. The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.
次要结局
- Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason(30 days)
- The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients(30 days)