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

NCT ID: NCT06300892

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-05-01

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing open GI surgery

Patients with SSI

No intervention

Intervention Type: OTHER

samples from the incision site and GI tract collected

Control group

age-, sex-, diagnosis-, and wound class-matched control patients without SSI

No intervention

Intervention Type: OTHER

samples from the incision site and GI tract collected

Interventions

No intervention

samples from the incision site and GI tract collected

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Rickard

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kathryn Vera

Role: CONTACT

giero002@umn.edu

612-625-5018

Facility Contacts

Kathryn Vera

Role: primary

Other Identifiers

SURG-2023-31841

Identifier Type: -

Identifier Source: org_study_id