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Completed

NCT Number: NCT06681935

Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

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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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Infections Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Stomatognathic Diseases Surgical Wound Infection Wound Infection

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide signed and dated informed consent form. Subjects must have the capacity to consent for themselves.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Aged 21 years or older.
  • Planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered.
  • 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.
  • History of oral or oropharyngeal cancer.

Exclusion criteria

  • Allergy to ampicillin/sulbactam.
  • Vulnerable populations including pregnant women and prisoners.

Treatment and study plan

Oral Cavity Reconstruction

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.

Primary outcomes

  1. Source of bacteria leading to a surgical site infection

    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).

Secondary outcomes

  1. Tissue antibiotic correlations

    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.

  2. Plasma antibiotic correlations

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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