Open GI SurgeryNCT06300892
Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
An observational study of Open GI Surgery, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open GI Surgery
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 15 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults over the age of 18 years, who are undergoing open abdominal surgery with a midline incision.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
- Conditions
- Open GI Surgery
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
samples from the incision site and GI tract collected
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing open GI surgery | Patients with SSI Receives: Other: No intervention | |
| Control group | age-, sex-, diagnosis-, and wound class-matched control patients without SSI Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
alpha diversity composition
Alpha diversity composition at the surgical incision site at multiple time points
Measured: Baseline, Day 30 post-op
microbial community composition
microbial community composition at the surgical incision site at multiple time points
Measured: Baseline, Day 30 post-op
pathogenic strain of bacteria
Pathogenic strain of bacteria at SSI compared with pathogens isolated from skin and/or GI tract microbiome
Measured: Baseline, Day 30 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open GI SurgeryStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Rickard, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300892
- Sponsor's protocol ID
- SURG-2023-31841
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
- ClinicalTrials.gov ID
- NCT06300892
- Acronym / sponsor ID
- SURG-2023-31841
- Conditions
- Open GI Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing open GI surgery | – | Other: No interventionPatients with SSI |
| Control group | – | Other: No interventionage-, sex-, diagnosis-, and wound class-matched control patients without SSI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults over the age of 18 years, who are undergoing open abdominal surgery with a midline incision.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsamples from the incision site and GI tract collected | Other | Control group, Patients undergoing open GI surgery |
Primary outcome
alpha diversity composition
Time frame: Baseline, Day 30 post-op
Alpha diversity composition at the surgical incision site at multiple time points
microbial community composition
Time frame: Baseline, Day 30 post-op
microbial community composition at the surgical incision site at multiple time points
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Rickard principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open GI Surgery, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alpha diversity composition (time frame: Baseline, Day 30 post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.