Antibiotics After Breast Reduction:Clinical Trial With Randomization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Surgical site infection in the postoperative of reduction mammaplasty.
研究概览
简要总结
This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.
详细描述
Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.
Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.
The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.
Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast hypertrophy
- •Body mass index between 19 to 30 kg/m2
排除标准
- •Patients undergoing a surgical procedure in the breast
- •Diagnosis of breast pathology
- •Childbirth or lactation less than a year
- •Uncontrolled comorbidities
- •Use of immunosuppressive drugs
- •Misuse of capsules supplied
- •Absence during the weekly follow-up
研究组 & 干预措施
Antibiotics Group
Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
干预措施: Cephalexin (Drug)
Placebo Group
Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
干预措施: Placebo (Drug)
结局指标
主要结局
Surgical site infection in the postoperative of reduction mammaplasty.
时间窗: 30 days postoperatively
After surgery, the patients will be followed for 30 days and surgical site infection rates will be observed in both groups, according to the CDC criteria.
次要结局
未报告次要终点
研究者
Edgard da Silva Garcia
Edgard da Silva Garcia, Professor, Universidade do Vale do Sapucaí
Federal University of São Paulo