Clinical trial NCT06681935: Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Official title: Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Cancer
Keywords: Surgical Site Infection
Oral Cavity Reconstruction
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2024-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The projected sample size is 40 patients over 2 years. The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction, which includes a planned surgical connection from the oral cavity to the neck soft tissues which is repaired through free or pedicled flap reconstruction.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Source of bacteria leading to a surgical site infection
timeFrame: Up to 30 days
Secondary outcomes:
measure: Tissue antibiotic correlations
timeFrame: Up to 30 days
measure: Plasma antibiotic correlations
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Joseph Zenga, MD
role: PRINCIPAL_INVESTIGATOR
References: