The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 602
- 试验地点
- 4
- 主要终点
- Surgical Site infection Rate
研究概览
简要总结
A randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.
详细描述
A randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. Statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients ages 18-50 years;
- •medically competent (no proxies or prisoners); and
- •multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age.
排除标准
- •Inability to obtain informed consent;
- •fetal death;
- •immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.
结局指标
主要结局
Surgical Site infection Rate
时间窗: 6 weeks postoperatively
Cellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.
次要结局
未报告次要终点
研究者
Peter R Cole, MD
MD
Albany Medical College