Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- pathogenic strain of bacteria
研究概览
简要总结
This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.
- Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.
- Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •We will include adult patients (age ≥ 18 years)
- •Undergoing open abdominal surgery during the study period.
- •Open abdominal surgery will include any abdominal procedure entering the peritoneal cavity through a midline incision with a skin incision that is 5cm or greater.
排除标准
- •Patients with planned minimally invasive surgery including laparoscopic or robotic surgery as these patients have lower rates of surgical site infections (SSIs). Patients who have a laparoscopic or robotic surgery converted to open surgery will be excluded.
- •Appendectomy and cholecystectomy as these patients have lower risk of SSI.
- •Vascular, gynecological, obstetric, urological or transplantation.
- •Trauma patients.
- •Patients without source control at the index operation including those with an open abdomen, no fascial closure, or temporary abdominal closure device (such as abthera dressing).
- •Pediatric patients (age<18 years).
- •Patients who decline swab/specimen collection.
研究组 & 干预措施
Patients undergoing open GI surgery
Patients with SSI
干预措施: No intervention (Other)
Control group
age-, sex-, diagnosis-, and wound class-matched control patients without SSI
干预措施: No intervention (Other)
结局指标
主要结局
pathogenic strain of bacteria
时间窗: Baseline, Day 30 post-op
Pathogenic strain of bacteria at SSI compared with pathogens isolated from skin and/or GI tract microbiome
alpha diversity composition
时间窗: Baseline, Day 30 post-op
Alpha diversity composition at the surgical incision site at multiple time points
microbial community composition
时间窗: Baseline, Day 30 post-op
microbial community composition at the surgical incision site at multiple time points
次要结局
未报告次要终点