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| ID | Type | Description | Link |
|---|---|---|---|
| R21DE032844 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing Oral Cavity Reconstruction | The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical College of Wisconsin Cancer Center Clinical Trials Office | Contact | 866-680-0505 | 8900 | cccto@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Zenga, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert & the Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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Whole genome sequencing may be included as part of the genetic testing for this research. Genetic testing will only be performed on microbial samples.
| 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. |
| Up to 30 days |
| D009057 |
| Stomatognathic Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |