Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Location status: Recruiting
NCT Number: NCT06681935
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.
Interested in participating?
Request Info21 year and older
All sexes
Observational
Milwaukee, Wisconsin, 53226, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 30 days
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
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
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.
Contact information is provided by the study sponsor or research team.
Medical College of Wisconsin
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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