Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

NCT06681935 | Recruiting DMC

• 2 other identifiers: PRO00052346R21DE032844
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Keywords

Surgical Site Infection; Oral Cavity Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tissue antibiotic correlations

  Up to 30 days

• Plasma antibiotic correlations

  Up to 30 days

Study Arms (1)

Subjects undergoing Oral Cavity Reconstruction

The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction.

Procedure: Oral Cavity Reconstruction

Interventions

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.

Subjects undergoing Oral Cavity Reconstruction

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole genome sequencing may be included as part of the genetic testing for this research. Genetic testing will only be performed on microbial samples.

MeSH Terms

Conditions

Mouth Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Zenga, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: April 29, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)