Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-29

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oral Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects undergoing Oral Cavity Reconstruction

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

Oral Cavity Reconstruction

Intervention Type PROCEDURE

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.

Interventions

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Oral 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.