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NCT06681935 | NOT YET RECRUITING | Oral Cancer

Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Sponsor:

Medical College of Wisconsin

Information provided by (Responsible Party):

Joseph Zenga

Brief 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.

Condition or disease

Oral Cancer

Intervention/treatment

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Actual Study Start Date : 2025-01-02
Estimated Primary Completion Date : 2027-01-02
Estimated Study Completion Date : 2027-01-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Location Details

NCT06681935

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How to Participate

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Locations

Not yet recruiting

United States, Wisconsin

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226