Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Completed

Conditions studied: Oral Cancer

In brief

The study design is an observational cohort study of patients undergoing standard of care oral cavity reconstruction. An observational study is required to prospectively evaluate microbial and antibiotic mechanisms underlying surgical site infection after oral cavity reconstruction.

Key facts

Study ID

NCT06681935

Run by

Medical College of Wisconsin

People needed

40

Starts

2025-04-29

Expected to finish

2026-07-24

Last updated by the study team

2026-08-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide signed and dated informed consent form. Subjects must have the capacity to consent for themselves.
• Willing to comply with all study procedures and be available for the duration of the study.
• Aged 21 years or older.
• Planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered.
• Oral cavity reconstruction surgery will be defined as any surgical procedure which includes a planned connection from the oral cavity to the neck soft tissues which is repaired with a free or regional tissue flap.
• History of oral or oropharyngeal cancer.

You may not qualify if…

• Allergy to ampicillin/sulbactam.
• Vulnerable populations including pregnant women and prisoners.

Where it is running

• Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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