Understanding how the microbiome affects surgical site infections in open GI surgery
Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
This study looks at how the bacteria in the gut and around surgical wounds might affect the chances of getting infections after open gastrointestinal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06300892 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the microbiome and surgical site infections (SSIs) in patients undergoing open gastrointestinal surgery. During the surgery, samples will be collected from the incision site and gastrointestinal tract, and patients will be monitored for up to 30 days postoperatively for signs of SSIs. The study aims to compare the microbiome diversity and composition between patients who develop SSIs and matched controls without SSIs, as well as identify specific bacterial strains associated with infections. This research could provide insights into the pathogenesis of SSIs and inform future prevention strategies.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older undergoing open abdominal surgery with a midline incision.
Not a fit: Patients undergoing minimally invasive surgeries or those with lower risk of SSIs, such as appendectomy or cholecystectomy, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention of surgical site infections, enhancing patient outcomes after surgery.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a potential link between the microbiome and surgical site infections, suggesting a promising area of investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Rickard — University of Minnesota
- Study coordinator: Kathryn Vera
- Email: giero002@umn.edu
- Phone: 612-625-5018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.