Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Medical College of Wisconsin

Status: Enrolling

Conditions: Oral Cancer

Treatments: Procedure: Oral Cavity Reconstruction

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06681935

R21DE032844 (U.S. NIH Grant/Contract)

PRO00052346

Details and patient eligibility

About

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.

Full description

This is a single institution study at the Medical College of Wisconsin, given the feasibility of projected sample size accrual as well as the clinical and translational expertise at this location for investigating surgical site infection after oral cavity reconstruction. Biospecimens collected will include oral, nasal, pharyngoesophageal, and skin microbial swabs, blood, and discard tissue samples obtained during standard of care oral cavity reconstruction surgery and an oral swab and nasal swab obtained post-operatively.

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Subjects undergoing Oral Cavity Reconstruction

Description:

The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction.

Treatment:

Procedure: Oral Cavity Reconstruction