Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Source of bacteria leading to a surgical site infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •History of oral or oropharyngeal cancer.
排除标准
- •Allergy to ampicillin/sulbactam.
- •Vulnerable populations including pregnant women and prisoners.
研究组 & 干预措施
Subjects undergoing Oral Cavity Reconstruction
The cohort will be oral cancer patients undergoing standard of care oral cavity reconstruction.
干预措施: Oral Cavity Reconstruction (Procedure)
结局指标
主要结局
Source of bacteria leading to a surgical site infection
时间窗: Up to 30 days
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).
次要结局
- Tissue antibiotic correlations(Up to 30 days)
- Plasma antibiotic correlations(Up to 30 days)
研究者
Joseph Zenga
Associate Professor
Medical College of Wisconsin