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Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

ConditionOral Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to ampicillin/sulbactam.

Vulnerable populations including pregnant women and prisoners.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Oral Cavity Reconstruction

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Subjects undergoing Oral Cavity Reconstruction1 intervention

Trial outcomes

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).

Time frame
Up to 30 days

Secondary outcomes

1

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.

Time frame
Up to 30 days
2

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.

Time frame
Up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Source ClinicalTrials.gov
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