Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Launched by MEDICAL COLLEGE OF WISCONSIN · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how infections can occur after surgery to reconstruct the oral cavity in patients with oral cancer. Specifically, the researchers want to understand the role of bacteria and antibiotics in these infections. This type of study involves observing patients who are receiving standard treatment rather than testing a new drug or procedure.

To participate in the study, you need to be at least 21 years old and have a history of oral or oropharyngeal cancer. You must also be planning to have surgery that connects your mouth to the neck and receive a specific antibiotic called ampicillin/sulbactam to help prevent infections. Participants will need to provide consent and be willing to follow the study procedures throughout its duration. The trial is not yet recruiting participants, but it aims to gather important information to improve the care of patients undergoing these types of surgeries in the future.

Gender

ALL

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.