Clinical trial · Observational
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
NCT06681935CI-TRIAL-00120607completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Cavity Reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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).
Secondary outcomes (2)
- measure
- Tissue antibiotic correlations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.