RECRUITING

Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

Quick Facts

Study Start:2025-04-29
Study Completion:2027-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06681935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provide signed and dated informed consent form. Subjects must have the capacity to consent for themselves.
  2. 2. Willing to comply with all study procedures and be available for the duration of the study.
  3. 3. Aged 21 years or older.
  4. 4. Planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered.
  5. 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. 6. History of oral or oropharyngeal cancer.
  1. 1. Allergy to ampicillin/sulbactam.
  2. 2. Vulnerable populations including pregnant women and prisoners.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
866-680-0505
cccto@mcw.edu

Principal Investigator

Joseph Zenga, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Joseph Zenga, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2027-05-01

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

  • Surgical Site Infection
  • Oral Cavity Reconstruction

Additional Relevant MeSH Terms

  • Oral Cancer