Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- Surgical Site Infection Rate
研究概览
简要总结
Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.
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
- Single (Outcomes Assessor)
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
- •Preoperatively not infected/dirty Surgical Site
- •Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)
排除标准
- •Emergent surgery
- •Local/locoregional procedures
- •Laparoscopic operation
- •Minor abdominal operations (e.g. hernia repair, colostomy closure)
- •Malign hyperthermia
- •Signs of active infection or fever
- •Immunosuppression
- •Severe malnutrition
- •Kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period
研究组 & 干预措施
Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
干预措施: Forced Air Warming blanket (Device)
Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
干预措施: Prewarming and perioperative warming with Forced Air Warming device and its blankets. (Other)
结局指标
主要结局
Surgical Site Infection Rate
时间窗: Postoperative 30 days
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n\<30), (p=0.044 chi-square )
次要结局
- Maintaining Normothermia Rate(Surgery day)
研究者
Ali Kadir Değirmenci
Asistant Investigator, MD
Dokuz Eylul University