Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

N/ARecruitingNCT06681935

Medical College of Wisconsin40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Oral Cancer

Interventions

Oral Cavity ReconstructionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

Tissue antibiotic correlations

This is the number of subjects with tissue antibiotic concentrations that correlate with surgical site infection. This will be accomplished by liquid chromatography/mass spectrometry (LC-MS) to assess for antibiotic concentration in tissue and blood during surgery.

Time frame: Up to 30 days

Plasma antibiotic correlations

This is the number of subjects with plasma antibiotic concentrations that correlate with surgical site infection. This will be accomplished by liquid chromatography/mass spectrometry (LC-MS) to assess for antibiotic concentration in tissue and blood during surgery.

Time frame: Up to 30 days

Central Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505 cccto@mcw.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.