Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Eligibility

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 details

Open GI Surgery

NCT06300892

University of Minnesota

15 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.