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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer
• Intervention / Treatment: Procedure: 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
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects undergoing Oral Cavity Reconstruction; The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Source of bacteria leading to a surgical site infection	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).	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue antibiotic correlations	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.	Up to 30 days
Plasma antibiotic correlations	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.	Up to 30 days

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Joseph Zenga, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Actual): July 24, 2026
• Study Completion (Actual): July 24, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Oral Cavity Reconstruction
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Infections; Head and Neck Neoplasms; Wound Infection; Pathological Conditions, Signs and Symptoms; Mouth Neoplasms; Surgical Wound Infection
• Other Study ID Numbers: PRO00052346; R21DE032844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No