NCT03554148

Bacteria and Intestinal Translocation in Surgery (Bandit)

Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 209 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
OTHER	No intervention	This is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection.

Timeline

• Start date: 2017-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-06-12
• Last updated: 2022-05-18

Locations

1 site across 1 country: Switzerland