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

March 1, 2024 updated by: University of Minnesota

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing open GI surgery
Patients with SSI
Other: No intervention
samples from the incision site and GI tract collected
Control group
age-, sex-, diagnosis-, and wound class-matched control patients without SSI
Other: No intervention
samples from the incision site and GI tract collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alpha diversity composition
Time Frame: Baseline, Day 30 post-op
Alpha diversity composition at the surgical incision site at multiple time points
Baseline, Day 30 post-op
microbial community composition
Time Frame: Baseline, Day 30 post-op
microbial community composition at the surgical incision site at multiple time points
Baseline, Day 30 post-op
pathogenic strain of bacteria
Time Frame: Baseline, Day 30 post-op
Pathogenic strain of bacteria at SSI compared with pathogens isolated from skin and/or GI tract microbiome
Baseline, Day 30 post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Jennifer Rickard, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURG-2023-31841

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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