NCT06681935 Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
| NCT ID | NCT06681935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Oral Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-04-29 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Provide signed and dated informed consent form. Subjects must have the capacity to consent for themselves. 2. Willing to comply with all study procedures and be available for the duration of the study. 3. Aged 21 years or older. 4. Planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered. 5. 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. 6. History of oral or oropharyngeal cancer. Exclusion Criteria: 1. Allergy to ampicillin/sulbactam. 2. Vulnerable populations including pregnant women and prisoners.
Contact & Investigator
Joseph Zenga, MD
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT06681935 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Oral Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06681935 currently recruiting?
Yes, NCT06681935 is actively recruiting participants. Contact the research team at cccto@mcw.edu for enrollment information.
Where is the NCT06681935 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06681935 clinical trial?
NCT06681935 is sponsored by Medical College of Wisconsin. The principal investigator is Joseph Zenga, MD at Medical College of Wisconsin. The trial plans to enroll 40 participants.
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