300 Participants Needed

Surgical Site Infections for Abdominal Surgery

KV
Overseen ByKathryn Vera
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines why some patients develop infections after open abdominal surgery. Researchers aim to determine if certain bacteria on the skin or in the gut during surgery cause these infections. They will compare patients who develop infections with those who do not, focusing on the types of bacteria present. This study targets adults undergoing open abdominal surgery with a large incision. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how surgical site infections (SSIs) develop by studying the microbiome of patients undergoing open gastrointestinal (GI) surgery. Unlike traditional treatments that focus on treating infections after they occur, this research could lead to preventative strategies by understanding the role of bacteria in wound healing and infection. By matching patients with and without SSIs in terms of age, sex, diagnosis, and wound class, researchers hope to pinpoint specific microbial factors that contribute to or protect against these infections. This could pave the way for innovative approaches to prevent SSIs, potentially reducing the reliance on antibiotics and improving patient outcomes.

Who Is on the Research Team?

JR

Jennifer Rickard

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Inclusion Criteria

I will have open abdominal surgery during the study.
I had surgery with a large cut in my belly area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Sample Collection

Patients undergo open GI surgery, and samples are collected from the incision site and GI tract

1 day
1 visit (in-person)

Postoperative Monitoring

Patients are monitored for signs of surgical site infections (SSI) up to 30 days postoperatively

30 days
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial postoperative period

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Patients undergoing open GI surgeryExperimental Treatment1 Intervention
Group II: Control groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+