Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Detection of bacterial DNA in liver biopsy
研究概览
简要总结
Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. Preoperatively baseline health data is collected and a skin swab and rectal swab for baseline skin and gut microbiota is taken. During the surgery additional clinical data and additional samples will be obtained. Additional samples include: rectal swab, biopsies of the resected specimen (lymph node, peritoneum, intestinal content, mucosa), venous blood sample (7.5ml) at the end of the operation, liver biopsy and skin biopsy. Postoperative health data is recorded. If a surgical site infection occurs a swab is taken too. With 16 sRNA (small ribonucleic acid) based sequencing the investigators will quantify the abundance of the different bacterial species in all samples. Primary outcome will be to assess a difference of 16sRNA signal in the liver and lymph node biopsies between patients with and patients without surgical site infection. Secondary outcomes include variables predicting the occurence of surgical site infections and a model describing the way bacteria may take to cause wound infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Informed Consent
- •All Gender
- •Elective Abdominal Surgery
- •Age > 18
- •All approached (laparoscopic, open)
- •All ethnic and sociodemographic backgrounds
- •Sufficient knowledge of the study language (German)
排除标准
- •pregnant or lactating women
- •no operation performed (i.e. only planned)
- •insufficient knowledge of project language (German)
- •lack of informed consent
- •known colonization with multi-resistant bacteria (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or extended spectrum betalactamase (ESBL))
- •known cirrhotic liver disease
研究组 & 干预措施
SSI
This group receives an additional swab of the surgical site infection. Follow up is terminated at the occurence of SSI.
干预措施: No intervention (Other)
No SSI
This group is systematically followed up until 30 days after surgery (one year if a implant is implanted, e.g. mesh) by a third party (www.swissnoso.ch).
干预措施: No intervention (Other)
结局指标
主要结局
Detection of bacterial DNA in liver biopsy
时间窗: day 0 (operation day)
Rationale: One of the aims is to test how the liver acts as primary barrier for blood-borne bacteria during the operation. Sampling: During elective abdominal surgery a biopsy with the Tru-Cut™ Needle (Baxter healthcare Co., 16G Chicago, USA) is performed as recommended by the manufacturer. Hemostasis is achieved by Application of mono-polar Electrocautery. Processing: The sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: Polymerase chain reaction (PCR) with bacteria specific primers, Sequencing of the PCR product (IonTorrent) to determine the present microbiota (species if possible, at least families). The difference in positive/negative liver probes is compared for patients with and without surgical site infections (Chi squared Test).
次要结局
- Number of patients with surgical site infection (SSI)(outpatient visit, usually around 7 to 21 days before operation)
- Modelling bacterial travel behaviour in multimodal networks(day 0)
- Baseline skin and gut microbiota(outpatient visit, usually around 7 to 21 days before operation)
- Detection of bacterial DNA in mesenteric lymph node(day 0 (operation day))