Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
研究概览
详细说明
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.
After completion of study treatment, patients are followed up at 30 days.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
North Carolina
-
Winston-Salem、North Carolina、美国、27157
- Comprehensive Cancer Center of Wake Forest University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Arm I (SSD)
Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.
|
Receive SSD
Receive NPT
|
|
实验性的:Arm II (NPT)
Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.
|
Receive SSD
Receive NPT
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间: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.
|
30 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason
大体时间:30 days
|
30 days
|
|
The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients
大体时间:30 days
|
30 days
|
合作者和调查者
调查人员
- 首席研究员:Perry Shen、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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