Actively Recruiting
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Led by Medical College of Wisconsin · Updated on 2026-05-22
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an observational cohort study to better understand surgical site infections in patients with oral cancer undergoing standard oral cavity reconstruction. This study aims to explore the microbial sources and antibiotic factors that may contribute to infections after surgery. The research is taking place at the Medical College of Wisconsin, which offers the necessary clinical and translational expertise for this investigation. Participants will undergo standard oral cavity reconstruction surgery, which involves creating a surgical connection between the oral cavity and neck soft tissues repaired using tissue flap techniques. As part of the study, various biospecimens will be collected, including oral, nasal, pharyngoesophageal, and skin microbial swabs, blood samples, and discarded tissue obtained during surgery. Additional oral and nasal swabs will be taken post-operatively to monitor changes. During the study, participants will be monitored for up to 30 days to determine the bacterial sources leading to surgical site infections. Researchers will also assess correlations between antibiotic levels in tissue and plasma samples. Participants will be asked to comply with study procedures and remain available throughout the study duration. The study does not involve any intervention beyond standard care, focusing on observation and sample collection to achieve its goals.
CONDITIONS
Brief Title
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent form, with capacity to consent.
- Willing to comply with all study procedures and available for the study duration.
- Aged 21 years or older.
- Planned to undergo standard oral cavity reconstruction surgery with ampicillin/sulbactam antibiotic prophylaxis.
- Oral cavity reconstruction involves a planned connection from the oral cavity to neck soft tissues repaired with a free or regional tissue flap.
- History of oral or oropharyngeal cancer.
You will not qualify if you...
- Allergy to ampicillin/sulbactam.
- Vulnerable populations including pregnant women and prisoners.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo standard of care oral cavity reconstruction surgery involving a planned surgical connection repaired with a free or regional tissue flap. Biospecimens including oral, nasal, pharyngoesophageal, skin microbial swabs, blood, and discarded tissue samples are collected during surgery.
1 surgical visit (in-person)
Duration - Up to 30 days
Participants have oral and nasal swabs collected post-operatively to monitor for surgical site infection over the following 30 days.
Approximately 2 to 3 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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