NCT02241915已完成4 期
Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of SSI with and without microbial sealant.
研究概览
简要总结
Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean contaminated colorectal procedures (Class 2).
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
- 是
入选标准
- •Nonemergent colon and/or rectal abdominal surgical procedures
- •Women of child-bearing potential must have a negative serum HCG assay prior to surgery
- •Ages ≥18 years.
排除标准
- •Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
- •Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.
- •Undergoing a significant concomitant surgical procedure (e.g., Whipple & organ transplant surgery).
- •The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy.
- •History of prior laparotomy within the last 60 days of this planned procedure.
- •Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
- •Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7
- •Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.
- •Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
- •Receiving antibiotic therapy within the 1 week prior to the date of surgery.
- •Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
- •Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.
- •History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
- •History of major organ transplantation, including bone marrow transplantation.
- •Taking systemic steroids >10 mg prednisone daily or remicade within 2 weeks prior to surgery or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count <
- •Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
- •Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
结局指标
主要结局
Incidence of SSI with and without microbial sealant.
时间窗: 15 Months
Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).
次要结局
- Subgroup incidence of SSI with and without microbial sealant(15 months)
研究者
Michael Doorly
Faculty Fellow
University of Southern California
研究点 (2)
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