Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in microbiome alpha diversity
研究概览
简要总结
This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.
详细描述
PRIMARY OBJECTIVE:
I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.
SECONDARY OBJECTIVES:
I. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.
II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects with early stage melanoma (stage I-II)
- •Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
- •Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
排除标准
- •Use of antibiotics within the three months prior to surgery
- •Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics
- •Presence of an infection at the time of surgery
- •Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
- •American Society of Anesthesiologists (ASA) grade > IV
- •Refusal to participate in the study
- •Patients who are pregnant will not be included in this study
研究组 & 干预措施
Arm A (cefazolin, surgical resection)
Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
干预措施: Resection (Procedure)
Arm B (surgical resection)
Patients undergo standard of care surgical resection.
干预措施: Resection (Procedure)
Arm A (cefazolin, surgical resection)
Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
干预措施: Cefazolin (Drug)
结局指标
主要结局
Change in microbiome alpha diversity
时间窗: Baseline up to 2 weeks post-surgery
The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.
次要结局
- Change in microbiome diversity(Baseline up to 3 months post-surgery)
- Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines(Up to 3 months post-surgery)
- Change in relative abundance of microbes(Baseline, at 2 weeks post-surgery, and 3 months post-surgery)
- Wound (surgical site) infection rate(Up to 3 months post-surgery)