NCT06300892

Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Open GI Surgery

Interventions

Type	Name	Description
OTHER	No intervention	samples from the incision site and GI tract collected

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-03-08
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States