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

Conditions

• Open GI Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• No intervention — OTHER
  samples from the incision site and GI tract collected

Study Details

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.

Key Dates

Start date

Apr 1, 2024

Status verified

May 2026

Primary completion

Jun 15, 2026

Completion

Jul 30, 2026

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Patients undergoing open GI surgery
  Patients with SSI
• Arm: Control group
  age-, sex-, diagnosis-, and wound class-matched control patients without SSI

Primary Outcome Measure

alpha diversity composition [ Time Frame: Baseline, Day 30 post-op ]

Central Contacts

• Kathryn Vera
  612-625-5018
  [email protected]

Locations (1)

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