Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

NCT ID: NCT06681935Sponsor: Medical College of WisconsinLast updated: 2026-05-22

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.

Detailed 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.

Arms & interventions

  • ProcedureOral Cavity Reconstruction

    This procedure includes a planned surgical connection from the oral cavity to the neck soft tissues which is repaired through free or pedicled flap reconstruction.

Outcome measures

Primary

  • Source of bacteria leading to a surgical site infection

    This is the number of subjects with surgical site infections with bacteria that originates from the oral cavity. This will be determined by metagenomic mapping of bacterial strains causing surgical site infection back on to the metagenomic samples from their anatomic source (oral cavity, nasal cavity, pharyngoesophagus, donor site skin).

    Time frame: Up to 30 days

Secondary

  • Tissue antibiotic correlations

    Time frame: Up to 30 days

  • Plasma antibiotic correlations

    Time frame: Up to 30 days

Eligibility criteria

Sex: AllAge: 21 Years and olderHealthy volunteers: No
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.

Study locations (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Joseph Zenga, MD · Contact
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery | Cancerify