Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1,037
- 主要终点
- Number of Sternal Wound Infections
研究概览
简要总结
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.
详细描述
During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Able to sign Informed Consent and Release of Medical Information Form
- •Age ≥ 18 years
- •Undergoing cardiac surgery with complete sternotomy (including re-operations)
排除标准
- •Evidence of active infection (any culture positive or blood positive infection)
- •Undergoing organ transplantation
- •Patients with known hypersensitivity to vancomycin
- •Pregnant or nursing women
- •Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
研究组 & 干预措施
Vancomycin
During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water
干预措施: Vancomycin (Drug)
Control
During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin
干预措施: No Vancomycin (Other)
结局指标
主要结局
Number of Sternal Wound Infections
时间窗: 3 months postoperative
The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
次要结局
- Adverse Events(1 year postoperative)
- Hospitalization(1 year postoperative)
- Cost Analysis for Sternal Wound Infection Treatment(1 year postoperative)
- Number of Participants With Use of Prophylactic Antibiotics(Assessed before surgery)
- Number of Sternal Wound Infections(1 year postoperative)