Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Recruiting

• Conditions: Oral Cancer

• Registration Number: NCT06681935
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-07
• Study First Posted: 2024-11-12
• Study Start: 2025-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Source of bacteria leading to a surgical site infection	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 Outcome Measures

Name	Time	Method
Tissue antibiotic correlations	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.
Plasma antibiotic correlations	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.

Trial Locations

Locations (1)

Froedtert & the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States