A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 2
- 主要终点
- Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
研究概览
简要总结
This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
详细描述
A randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
Women with breast cancer who will undergo elective MRM were recruited for the study. Excluded were patients with significant co-morbid factors, for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week, with known allergy to cephalosporins, and those with local infection. Patients were randomized to receive either transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for the presence of SSI and other complications weekly for 30 days.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically diagnosed breast cancer of age group 18-80 years old, ECOG 0-1, clinical stage I to IIIB, admitted to the surgery ward, who were scheduled for elective MRM.
排除标准
- •Women with significant co-morbid factors (diabetes mellitus, severe malnutrition, corticosteroid therapy), those scheduled for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week prior to surgery, with known allergy to cephalosporins, and those with local infection.
结局指标
主要结局
Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
时间窗: Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days
Mastectomy wounds were evaluated for the presence of SSI as defined by the Center for Disease Control and Prevention meeting the following criteria: infection that occurred within 30 days after the operative procedure and at least one of the following: 1. purulent drainage (culture documentation not required) 2. organism isolated from fluid/tissue of incision site 3. at least one sign of inflammation (erythema, local warmth of wound, induration) 4. wound is deliberately opened by the surgeon 5. physician declares the wound infected
次要结局
未报告次要终点