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

NCT06300892 | Recruiting

• 1 other identifier: SURG-2023-31841
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• alpha diversity composition

  Alpha diversity composition at the surgical incision site at multiple time points

  Baseline, Day 30 post-op

• microbial community composition

  microbial community composition at the surgical incision site at multiple time points

  Baseline, Day 30 post-op

• pathogenic strain of bacteria

  Pathogenic strain of bacteria at SSI compared with pathogens isolated from skin and/or GI tract microbiome

  Baseline, Day 30 post-op

Study Arms (2)

Patients undergoing open GI surgery

Patients with SSI

Other: No intervention

Control group

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

Other: No intervention

Interventions

No intervention OTHER

samples from the incision site and GI tract collected

Control group; Patients undergoing open GI surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults over the age of 18 years, who are undergoing open abdominal surgery with a midline incision.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples from the incision site and GI tract

Study Officials

• Jennifer Rickard

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Vera

CONTACT

612-625-5018; giero002@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: June 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)