Understanding infections after oral cancer surgery
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
This study looks at patients who have oral cancer surgery to see what causes infections afterward and how to prevent them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06681935 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on patients undergoing standard oral cavity reconstruction surgery to investigate the microbial and antibiotic mechanisms that lead to surgical site infections. Conducted at the Medical College of Wisconsin, the study will collect various biospecimens, including microbial swabs and blood samples, both pre- and post-operatively. The goal is to gain insights into the factors contributing to infections in this patient population, which could inform future preventive strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with a history of oral or oropharyngeal cancer who are scheduled for oral cavity reconstruction surgery.
Not a fit: Patients with allergies to ampicillin/sulbactam or those from vulnerable populations, such as pregnant women and prisoners, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and management of surgical site infections in patients undergoing oral cancer surgery.
How similar studies have performed: While this study is focused on a specific aspect of surgical site infections, similar observational studies have shown promise in understanding infection mechanisms in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milwaukee, Wisconsin
- Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Zenga, MD — Medical College of Wisconsin
- Study coordinator: Medical College of Wisconsin Cancer Center Clinical Trials Office
- Email: cccto@mcw.edu
- Phone: 866-680-0505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.