Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
研究概览
简要总结
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.
详细描述
Surgical Site infection after breast surgical procedures occurs more frequently than for other clean surgical procedures. Considering the large numbers of patients who undergo breast-related procedures per year and the increasing use of immediate breast reconstruction with placement of tissue expanders or immediate implant reconstruction, a surgical site infection involving the implant can result in its removal and a failed reconstruction.
The primary aim of the study is to determine if chlorhexidine disk application and irrigation of the drainage bulb with dilute Dakin's solution (buffered sodium hypochlorite solution)after tissue expander breast reconstruction or immediate implant reconstruction, effectively decreases rates of bacterial colonization in drain fluid compared to standard care.
Methods:
Patients undergoing bilateral immediate reconstruction with tissue expander placement will have one surgical site treated with standard drain care and the other treated with a drain antisepsis regimen. Drain antisepsis intervention will consist of two measures: 1) placement of a chlorhexidine sponge dressing at the drain exit site, and 2) twice daily irrigation of the drainage bulb with dilute Dakin's solution (buffered hypochlorite).
All patients will undergo semiquantitative cultures of the drain bulb at one week postoperatively. This culture will be repeated at the time of drain removal, with simultaneous cultures of the fluid in the bulb as well as an internal segment of each removed drainage tube. All patients will be evaluated for clinical signs of infection and for any adverse reactions to the drain antisepsis at the follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females or males age 18-90 able to give informed consent
- •Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction
- •May have either malignant or benign breast condition
排除标准
- •Antibiotic use in the fourteen days prior to surgical date
- •Undergoing unilateral tissue expander reconstruction
- •Documented allergy to chlorhexidine gluconate
- •Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease)
- •Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin
- •Pregnant women
- •Vulnerable subjects - prisoners, institutionalized individuals
- •Non-English speaking patients without adequate interpreter assistance
结局指标
主要结局
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
时间窗: Approximately 1 week after surgery
Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
时间窗: Approximately 1 week after surgery
次要结局
- Per Drain Analysis: Drain Bulb Fluid Colonization at Removal(Approximately one month after surgery)
- Number of Subjects With Surgical Site Infection Within 30 Days(Approximately 30 days after surgery)
- Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal(Approximately 2 weeks after surgery)
- Number of Subjects With Drain Tubing Colonization at Removal(Approximately two weeks after surgery)
- Number of Subjects With Surgical Site Infection Within 1 Year(Approximately one year after surgery)
- Per Drain Analysis: Drain Tubing Colonization at Removal(Approximately one month after surgery)