Antibiotic Prophylaxis in Gynecologic Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Surgical site infection
研究概览
简要总结
Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.
详细描述
It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic disease, in which there is indication of laparoscopic surgical approach, will be consecutively select. These women will be allocated in two arms, control and study, where control group will use placebo and study will receive intravenous cephazolin. These patients will be followed for 30 days according to Centers for Disease Control and Prevention criteria.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.
排除标准
- •body mass index over 30 Kg/m2
- •diabetes type I or II with glycated hemoglobin exceeding 6.5%
- •patients who are at surgical risk classification of the American Society of Anesthesiologists(ASA) as ASA III or higher
- •refusal to participate
- •postoperative antibiotic therapy for another indication clinical complication
研究组 & 干预措施
Placebo
Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.
干预措施: gynecologic laparoscopy (Procedure)
Placebo
Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.
干预措施: Placebo (Drug)
Cefazolin
Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.
干预措施: gynecologic laparoscopy (Procedure)
Cefazolin
Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.
干预措施: Cefazolin (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 30 days
Patients are followed weekly by a masked surgeon in regard to surgical site infecton (SSI), until the 30th postoperative day. Centers for Disease Control and Prevention's (CDC) criteria and classification were adopted.
次要结局
未报告次要终点
研究者
Fabiola Soares Moreira Campos
MD
Universidade do Vale do Sapucai