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OpenTrials
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NCT Number: NCT06300892

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Open GI Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

samples from the incision site and GI tract collected

Primary outcomes

  1. alpha diversity composition

    Time frame: Baseline, Day 30 post-op

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

  2. microbial community composition

    Time frame: Baseline, Day 30 post-op

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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.