Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of any samples successfully producing microbiome data
研究概览
简要总结
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of breast microbiome sampling using the study techniques
SECONDARY OBJECTIVES:
I. To define the differences in the gut and breast microbiomes between participants undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not.
II. To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
- •Age >= 18 years
- •Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
- •Ability to understand a written informed consent document, and the willingness to sign it
- •At least 4 weeks post-completion of chemotherapy or radiation therapy.
排除标准
- •Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •Pregnant or breastfeeding
- •Patients who have taken antibiotics within 90 days of the consent date
- •Patients who have taken probiotics within 90 days of the consent date
- •Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
- •Male patients
研究组 & 干预措施
Cohort A: Standard antibiotics
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
干预措施: Cephalexin (Drug)
Cohort B: No antibiotics
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection
结局指标
主要结局
Proportion of any samples successfully producing microbiome data
时间窗: 90 days
Feasibility based off of the success rates in producing microbiome data from tissue or aspirate samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.
Proportion of aspirate samples successfully producing microbiome data
时间窗: 90 days
Feasibility based off of the success rates in producing microbiome data from tissue samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.
Proportion of aspirate samples obtained successfully overall
时间窗: 90 days
The feasibility of success in obtaining samples from the tissue expander aspiration ports will be measured as a binary outcome (successful or not successful) over time (intra-operatively, week 1, week 2, week 3, and week 4). The investigators will assess and document success in obtaining a aspirate sample immediately at the time of sampling of each participant.
Proportion of tissue samples successfully producing microbiome data
时间窗: 90 days
Feasibility based off of the success rates in producing microbiome data from tissue samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.
Proportion of tissue samples obtained successfully over time
时间窗: 90 days
The feasibility of success in obtaining samples from breast tissue will be measured as a binary outcome (successful or not successful) over time (intra-operatively, week 1, week 2, week 3, and week 4). The investigators will assess and document success in obtaining a tissue sample immediately at the time of sampling of each participant.
Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)
时间窗: 90 days
The investigators will analyze the microbiomes between groups, between microbiome environments (gut v. breast, inter-individual). The correlate of change in breast microbiome over time will be compared to the total duration of antibiotics for Cohort A only. The measure of association ranges from +1 to -1, with a value of zero equal to no association.
次要结局
- Proportion of participants with post-operative infection(90 days)
- Number of overall identified microbes(90 days)
- Shannon Diversity Index Score for species of microbiome(90 days)