Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT06681935
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole genome sequencing may be included as part of the genetic testing for this research. Genetic testing will only be performed on microbial samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Source of bacteria leading to a surgical site infection', 'timeFrame': 'Up to 30 days', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Tissue antibiotic correlations', 'timeFrame': 'Up to 30 days', 'description': '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.'}, {'measure': 'Plasma antibiotic correlations', 'timeFrame': 'Up to 30 days', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Site Infection', 'Oral Cavity Reconstruction'], 'conditions': ['Oral Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide signed and dated informed consent form. Subjects must have the capacity to consent for themselves.\n2. Willing to comply with all study procedures and be available for the duration of the study.\n3. Aged 21 years or older.\n4. Planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered.\n5. 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.\n6. History of oral or oropharyngeal cancer.\n\nExclusion Criteria:\n\n1. Allergy to ampicillin/sulbactam.\n2. Vulnerable populations including pregnant women and prisoners.'}, 'identificationModule': {'nctId': 'NCT06681935', 'briefTitle': 'Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery', 'orgStudyIdInfo': {'id': 'PRO00052346'}, 'secondaryIdInfos': [{'id': 'R21DE032844', 'link': 'https://reporter.nih.gov/quickSearch/R21DE032844', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects undergoing Oral Cavity Reconstruction', 'description': 'The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction.', 'interventionNames': ['Procedure: Oral Cavity Reconstruction']}], 'interventions': [{'name': 'Oral Cavity Reconstruction', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Subjects undergoing Oral Cavity Reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Zenga, MD', 'role': 'CONTACT', 'email': 'jyzenga@mcw.edu', 'phone': '414-955-0889'}], 'facility': 'Froedtert & the Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Medical College of Wisconsin Cancer Center Clinical Trials Office', 'role': 'CONTACT', 'email': 'cccto@mcw.edu', 'phone': '866-680-0505', 'phoneExt': '8900'}], 'overallOfficials': [{'name': 'Joseph Zenga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Joseph Zenga', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}