Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infe… (NCT06300892) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
United States71 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on understanding how bacteria in the gut microbiome relate to surgical site infections in open GI surgery — does my specific situation and planned surgery make my case relevant to what this study is trying to learn?
2Since this trial is listed as 'active, not recruiting,' it means they're no longer enrolling new participants — are there similar observational studies looking at the microbiome and surgical site infections that I could still potentially be part of?
3The study is measuring things like microbial diversity and identifying pathogenic strains of bacteria — does this mean participants might have extra swabs, samples, or lab tests taken compared to standard care, and what would that involve for me practically?
4Because this appears to be an observational study trying to understand the causes of surgical site infections rather than test a new treatment, would participating in something like this have any direct impact on how my surgery or post-operative care would be managed?
5Given that surgical site infections are a known risk with open GI surgery, what steps are already standard practice to reduce that risk in my case, regardless of any research study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.