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Patients undergoing open GI surgery for Abdominal surgery

N/A
Recruiting
Led By Jennifer Rickard
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 30 post-op
Awards & highlights

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.

Eligible Conditions
  • Abdominal surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 30 post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 30 post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
alpha diversity composition
microbial community composition
pathogenic strain of bacteria

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients undergoing open GI surgeryExperimental Treatment1 Intervention
Patients with SSI
Group II: Control groupExperimental Treatment1 Intervention
age-, sex-, diagnosis-, and wound class-matched control patients without SSI

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Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,395 Previous Clinical Trials
1,553,025 Total Patients Enrolled
Jennifer RickardPrincipal InvestigatorUniversity of Minnesota
~200 spots leftby Dec 2025